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Vitamin D Deficiency Tied to Depression Risk With Chronic Kidney Disease

Vitamin D deficiency (VDD) is independently associated with increased depression risk in patients with chronic kidney disease (CKD), according to a study published online Jan. 26 in Frontiers in Nutrition.

I-Wen Chen, from Chi Mei Medical Center in Tainan City, Taiwan, and colleagues examined the association between VDD and the risk for depression. The analysis included 17,955 propensity-matched pairs of patients with CKD (aged 50 years and older) with VDD of ≤20 ng/mL or ≥30 ng/mL (control group), as measured within three months of CKD diagnosis.

The researchers found that VDD was associated with increased depression risk at one year (hazard ratio [HR], 1.929). This association remained at follow-up three years later. The finding was consistent across CKD stages, with similar risks in early CKD (HR, 1.977) and CKD stage 3 to 5 (HR, 1.981). Depression risk was higher among men with VDD (HR, 2.264) versus women (HR, 1.761). Higher depression risk was seen even with vitamin D insufficiency (20 to 30 ng/mL) versus normal levels (HR, 1.667).

"These findings suggest that maintaining adequate vitamin D levels might be important for mental health in patients with CKD, although randomized trials are needed to confirm whether supplementation can prevent depression in this population," the authors write.

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Bleeding Risks for Oral Anticoagulants and Aspirin Mostly Similar

Rates of major bleeding and intracranial hemorrhage are similar for apixaban and dabigatran versus aspirin, while rates are higher for rivaroxaban, according to a review published online Feb. 11 in the Annals of Internal Medicine.

Michael Ke Wang, M.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues estimated the differences in bleeding risks between therapeutic-dose nonvitamin K oral anticoagulants (NOACs) and single antiplatelet therapy using data from nine randomized controlled trials with 26,224 participants. All of the studies used aspirin as the antiplatelet therapy.

The researchers found that apixaban had similar rates of major bleeding and intracranial hemorrhage compared with aspirin (risk differences, 0.0 [95 percent confidence interval, −1.3 to 2.6] and −0.2 [95 percent confidence interval, −0.6 to 1.4] percentage points, respectively). Dabigatran also had similar rates of major bleeding and intracranial hemorrhage compared with aspirin (risk differences, 0.5 [95 percent confidence interval, −2.1 to 19.6] and 0.0 [95 percent confidence interval, −1.1 to 24.5] percentage points, respectively). Rivaroxaban had higher rates of major bleeding and intracranial hemorrhage than aspirin (risk differences, 0.9 [95 percent confidence interval, −0.1 to 3.7] and 0.3 [95 percent confidence interval, −0.1 to 79.7] percentage points, respectively). The certainty of evidence varied from low to moderate.

"Our findings are similar to those reported by a previous network meta-analysis, which found indirect evidence that therapeutic-dose rivaroxaban had the highest risk for bleeding out of the NOACs compared with aspirin when used for extended anticoagulation in this population," the authors write.

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Low Vitamin D in First Trimester Tied to Worse Outcomes

Low vitamin D levels during the first trimester of pregnancy are associated with higher rates of preterm birth and decreased fetal length, according to a study published online in the February issue of the American Journal of Clinical Nutrition.

Celeste Beck, Ph.D., M.P.H., from Pennsylvania State University in University Park, and colleagues examined whether first- and second-trimester maternal vitamin D status was associated with fetal growth patterns and pregnancy outcomes. The analysis included 351 participants with vitamin D measurements taken at six to 13 and 16 to 21 weeks of gestation.

The researchers found that vitamin D insufficiency (25-hydroxyvitamin D [25(OH)D] <50 nmol/L) was prevalent in 20 percent of participants in the first trimester. In the first trimester, each 10 nmol/L increase in 25(OH)D was associated with a 0.05 increase in length-for-age z-score but was not associated with weight or head circumference. Using the cutoff of <50 nmol/L, there were no differences in the risk for preterm birth or small for gestational age. However, among participants with first-trimester 25(OH)D <40 nmol/L compared with ≥80 nmol/L, the risk for preterm birth was 4.35 times higher. There was no association for second-trimester 25(OH)D and fetal growth patterns or with pregnancy outcomes.

"This research indicates that vitamin D levels -- along with iron, folate, and other essential nutrients in pregnancy -- should be monitored and understood by obstetricians and women early on to promote healthy birth outcomes," Beck said in a statement.

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Micronutrient Deficiencies Seen in More Than 45 Percent With Type 2 Diabetes

More than 45 percent of patients with type 2 diabetes (T2D) have micronutrient deficiencies, with the most prevalent deficiency being vitamin D, according to a meta-analysis published online Jan. 28 in BMJ Nutrition Prevention & Health.

Daya Krishan Mangal, Ph.D., from the Indian Institute of Health Management Research in Jaipur, and colleagues conducted a comprehensive assessment of the burden of multiple micronutrient deficiencies among patients with T2D. A total of 132 studies with 52,501 participants were included in the analysis.

The researchers found that the pooled prevalence of multiple micronutrient deficiencies was 45.30 percent among patients with T2D. The pooled prevalence was higher in women with T2D (48.62 percent) than in men (42.53 percent). The most prevalent micronutrient deficiency was vitamin D followed by magnesium (60.45 and 41.95 percent, respectively). The metformin-consuming group had higher B12 deficiency (28.72 percent). Across World Health Organization regions, there was variation seen in the prevalence of micronutrient deficiency.

"Micronutrient deficiencies may influence glucose metabolism and insulin signaling pathways, leading to the onset and progression of T2D," the authors write.

One author disclosed ties to Abbott, which funded the study.

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Certain Drug Types Associated With Risk for Dementia

Antimicrobials, vaccines, and anti-inflammatories are associated with a reduced risk for Alzheimer disease and dementia, while antipsychotics and drugs for diabetes are associated with an increased risk, according to a review published online Jan. 21 in Alzheimer's & Dementia: Translational Research & Clinical Interventions.

Benjamin R. Underwood, Ph.D., from the University of Cambridge in the United Kingdom, and colleagues conducted a systematic review to examine the association between a range of prescribed medications and dementia risk. Fourteen studies with administrative or medical records data from more than 130 million individuals and 1 million dementia cases were included.

The researchers found that some themes emerged for drug classes with biological plausibility, despite inconsistencies in identifying specific drugs that may modify Alzheimer disease or dementia risk. Reduced risk was seen in association with antimicrobials, vaccinations, and anti-inflammatories, while an increased risk was seen in association with diabetes drugs, vitamins and supplements, and antipsychotics. Evidence for antihypertensives and antidepressants was found to be conflicting.

"Though the results are not immediately clear-cut for individual drugs, some expected and some unexpected patterns have emerged," the authors write. "Understanding whether drugs in current use could be repurposed for use in dementia is an urgent priority and will become more important with the emergence of platform trials in the field."

One author disclosed ties to Lilly and TauRx.

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Nasal Epithelial Gene Expression IDs Asthma Endotypes in Children

Nasal epithelial gene expression can be used to characterize asthma endotypes and reveals that most participants from three studies of youths with asthma have nasal transcriptomic profiles with low T2 expression, according to a study published online Jan. 2 in the Journal of the American Medical Association.

Molin Yue, from the University of Pittsburgh, and colleagues examined asthma endotypes in youths aged 6 to 20 years by examining the distribution and characteristics of transcriptomic profiles in nasal epithelium. Samples were included from three studies: Stress and Treatment Response in Puerto Rican and African American Children with Asthma (156 youths); Epigenetic Variation and Childhood Asthma in Puerto Ricans (237 youths); and Vitamin D Kids Asthma (66 youths).

The researchers identified three transcriptomic profiles: high T2 expression, high T17 expression, and low expression in both pathways (T2HIGH, T17HIGH, T2LOW/T17LOW). Across studies, T2HIGH, T17HIGH, T2LOW/T17LOW were seen in 23 to 29 percent, 35 to 47 percent, and 30 to 38 percent of participants, respectively. The median total immunoglobulin E (IgE) and blood eosinophils were higher for the T2HIGH profile than for the T2LOW profile in each study. At least 50 percent of participants in all profiles had one or more positive allergen-specific IgE. A total of 3,516 and 2,494 differentially expressed genes were seen for the T2HIGH and T17HIGH profiles, respectively, in a differential meta-analysis. The T17HIGH and T2HIGH profiles were associated with interleukin 17 and neutrophil signaling pathways and interleukin 13 signaling pathways, respectively.

"This study showed that T2-low asthma endotypes (including T17HIGH and T2LOW/T17LOW transcriptomic profiles) were more prevalent than the T2HIGH profile in three studies of predominantly racially and ethnically minoritized youths with asthma," the authors write.

One author disclosed ties to the pharmaceutical industry.

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FDA Updates Meaning of 'Healthy' on Food Labels

THURSDAY, Dec. 19, 2024 (HeathDay News) -- The U.S. Food and Drug Administration wants to redefine the meaning of healthy food, issuing a new rule Thursday that changes the way food companies can claim their products are indeed nutritious.

What foods will qualify for the new designation?

Under the final rule, pretty much everything in the produce section -- whole fruits and vegetables -- would be considered healthy, as would other nutrient-rich foods like whole grains, dairy, eggs, beans, lentils, seafood, lean meat, nuts and seeds.

"It's critical for the future of our country that food be a vehicle for wellness. Improving access to nutrition information is an important public health effort the FDA can undertake to help people build healthy eating patterns," FDA Commissioner Dr. Robert Califf, said in an agency news release announcing the new rule. "It is vital that we focus on the key drivers to combat chronic disease, like healthy eating."

"Now, people will be able to look for the ‘healthy’ claim to help them find foundational, nutritious foods for themselves and their families," he added.

The idea is to simplify things for shoppers who are confused by nutrition fact labels that don’t give any real-world guidance on whether one product is better than another, the agency added.

Nutrition experts welcomed the change.

“It’s a terrific advance,” Dr. Dariush Mozaffarian, director of the Food is Medicine Institute at Tufts University in Boston, told NBC News. “For the first time, FDA will be judging foods not based on a handful of negative nutrients like calories or fat or salt, but on whether the food has healthy ingredients.”

The previous rule had a cap on total fat, which excluded products with heart-healthy fat, such as avocados, NBC News reported. Products could also qualify if they had at least 10% of the daily value for certain vitamins, calcium, iron, protein or fiber.

Manufacturers took advantage of that earlier rule.

“That led companies to fortify junk food and call them healthy,” Mozaffarian explained. Fruit juice could be labeled as “healthy” if they had enough vitamin C, despite a tremendous amount of added sugar.

The new rule eliminates that possibility. Products that can no longer claim to be healthy include fortified white bread and highly sweetened yogurts and cereals.

It’s one of the final moves from the Biden administration, and it's likely to be embraced by the incoming Trump administration, NBC News reported.

U.S. Department of Health and Human Services Secretary nominee Robert F. Kennedy Jr. has called for replacing ultra-processed food with healthier alternatives, to fight chronic diseases like type 2 diabetes.

Companies have until 2028 to comply with the new rule, and the FDA said it is also working on a healthy symbol that companies can add to packaging in the future.

“The updated definition should give consumers more confidence when they see the ‘healthy’ claim while grocery shopping," Nancy Brown, chief executive of the American Heart Association, said in a statement after the new rule was announced. "And we hope it will motivate food manufacturers to develop new, healthier products that qualify to use the 'healthy' claim."

More information

The World Health Organization has more on a healthy diet.

SOURCE: U.S. Food and Drug Administration, news release, Dec. 19, 2024; NBC News

Certain Foods May Cut Risk for Rheumatoid Arthritis

Moderate alcohol consumption and eating oily fish, fruits, and cereals may reduce the risk for rheumatoid arthritis (RA), according to a review published online Nov. 26 in Nutrients.

Yuanyuan Dong, from the School of Food Science and Nutrition at the University of Leeds in the United Kingdom, and colleagues conducted a systematic literature review and meta-analysis to assess dietary factors and RA risk.

Based on 30 included studies (2.99 million participants; 9,677 RA cases), the researchers found that each two-unit increase per week in total alcohol intake was linked to a 4 percent risk reduction (moderate certainty), while beer consumption was associated with a 10 percent reduction per two-unit increase per week (very low certainty). A 3 percent decrease in seropositive RA risk was seen with each two-unit increase per week in total alcohol intake (moderate certainty). Reduced risk was also seen with increased intakes of fruit (per 80 g/day: 5 percent reduction; moderate certainty) and cereals (per 30 g/day: 3 percent reduction; moderate certainty). However, tea consumption was associated with a 4 percent increased risk for RA per additional cup/day (moderate certainty). There were nonlinear associations seen for total coffee, vegetables, oily fish, and vitamin D supplementation.

"Optimizing dietary intake of certain food components may reduce RA risk, despite moderate-quality evidence," the authors write. "Further research is needed to confirm these associations and explore whether specific dietary patterns or nutrients could emerge as a viable strategy for RA prevention."

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USPSTF Recommends Against Vitamin D Supplementation for Fracture, Fall Prevention

The U.S. Preventive Services Task Force (USPSTF) recommends against vitamin D supplementation, with or without calcium, for preventing fractures and falls in older adults. These recommendations form the basis of a draft recommendation statement published online Dec. 17.

Researchers from the Agency for Healthcare Research and Quality in Rockville, Maryland, reviewed the evidence on supplementation with vitamin D, calcium, or both to prevent fractures and falls in community-dwelling adults. Twenty unique randomized controlled trials were included; eight were conducted exclusively among postmenopausal women and the rest included men (aged 50 years or older) and postmenopausal women. The researchers found that the pooled risk ratio for vitamin D supplementation, with or without calcium, was 0.99 (95 percent confidence interval, 0.86 to 1.13) compared with control, corresponding to an absolute risk difference of zero fewer hip fractures per 1,000 supplemented. For incidence of one or more falls, the pooled relative risk for vitamin D supplementation, with or without calcium, was 0.99 versus control (95 percent confidence interval, 0.97 to 1.01), corresponding to an absolute risk difference of five fewer participants with one or more falls per 1,000 supplemented.

Based on these findings, the USPSTF recommends against supplementation with vitamin D, with or without calcium, for the primary prevention of fractures or falls in community-dwelling postmenopausal women and men 60 years or older (D recommendation).

The draft recommendation statement and evidence review have been posted for public comment. Comments can be submitted from Dec. 17, 2024, through Jan. 21, 2025.

Draft Evidence Review

Draft Recommendation Statement

Comment on Recommendation Statement

Vitamin D Supplementation Does Not Reduce Risk for T2DM in Healthy Seniors

Vitamin D3 supplementation does not significantly reduce the risk for developing diabetes among older adults who are not at high risk for diabetes, according to a study published online Dec. 2 in Diabetologia.

Jyrki K. Virtanen, Ph.D., from the University of Eastern Finland in Kuopio, and colleagues conducted a five-year randomized trial involving 2,271 male and female participants aged 60 years and older and 65 years and older, respectively, who were free of cardiovascular disease or cancer and did not use diabetes medications. Participants were randomly assigned to receive placebo, 1,600 IU/day of vitamin D3, or 3,200 IU/day vitamin D3 (760, 744, and 767 participants, respectively).

The researchers identified 38 (5.0 percent), 31 (4.2 percent), and 36 (4.7 percent) type 2 diabetes events in the placebo, 1,600-IU/day, and 3,200-IU/day vitamin D3 groups, respectively. The hazard ratio was not significant when the two vitamin D3 arms were combined and compared with the placebo arm. The hazard ratios in the combined vitamin D3 arms versus placebo were not significant in analyses stratified by body mass index (BMI). In a subcohort of 504 participants with a mean serum 25-hydroxyvitamin D3 concentration of 74.5 nmol/L at baseline, there were no differences seen in changes in plasma glucose or insulin concentrations, BMI, or waist circumference during 24 months of follow-up.

"Our findings do not suggest benefits of long-term moderate- or high-dose vitamin D3 supplementation for incidence of type 2 diabetes or glucose metabolism or body size among generally healthy older vitamin D-sufficient men and women who were not at high risk for type 2 diabetes," the authors write.

Several authors disclosed ties to the pharmaceutical and nutrition industries.

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PIVKA-II-Based Model IDs Liver Cancer Risk in Hep C-Related Cirrhosis

Among patients with hepatitis C virus (HCV)-related cirrhosis with sustained virological response (SVR) to direct-acting antivirals (DAAs), a serum protein induced by vitamin K absence or antagonist-II (PIVKA-II)-based model is accurate for predicting hepatocellular carcinoma (HCC) risk, according to a study published online Nov. 21 in Alimentary Pharmacology & Therapeutics.

Gian Paolo Caviglia, Ph.D., from the University of Turin in Italy, and colleagues developed and validated a PIVKA-II-based model for HCC risk stratification in patients with HCV-related cirrhosis with SVR to DAAs. Data were included for 1,220 patients (Turin cohort, 531; Pisa cohort, 335; and Milan cohort, 354).

The researchers derived a model including PIVKA-II combined with age, sex, alanine transaminase, aspartate aminotransferase, gamma-glutamyl transferase, platelet count, albumin, and total bilirubin from the training cohort (Turin + Pisa), with a C-index of 0.72. The models showed a C-index of 0.71 in the validation cohort (Milan), with an area under the curve of 0.84 for identifying patients who developed HCC within 12 months of follow-up. The cumulative incidence of HCC was 2.7, 4.0, and 14.3 percent in the low-, medium-, and high-risk groups when the patients were categorized into three risk categories. In the low-risk group, no HCC occurred within three years of follow-up.

"Our model allowed the identification of patients at low risk of HCC development that may not need surveillance, reducing costs and harms from surveillance," the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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Current Prenatal Multivitamin, Mineral Labels Are Misleading

Current prenatal multivitamin and mineral (PMVM) labels are misleading and often exclude the presence of heavy metals, according to a study published online Nov. 18 in the American Journal of Clinical Nutrition.

Laura M. Borgelt, Pharm.D., from the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado Anschutz Medical Campus in Aurora, and colleagues analyzed 32 nonprescription and 15 prescription PMVMs regarding choline and iodine content, as well as arsenic, lead, and cadmium.

The researchers found that choline amounts were reported on 25.6 percent of products, including five within 20 percent of the claimed amount, two over the claimed amount by >20 percent, and five under the claimed amount by >20 percent. Iodine amounts were reported for 53.2 percent of products, including four within 20 percent of the claimed amount, 20 under the claimed amount by >20 percent, and one over the claimed amount by >20 percent. Amounts of arsenic, lead, and cadmium above United States Pharmacopeia purity limits were found in seven, two, and 13 PMVMs, respectively.

"Current PMVM labels are misleading with the potential to harm pregnant persons and fetuses through omission or inaccurate content of essential nutrients and inclusion of heavy metals," the authors write.

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Cognitive Behavioral Therapy Aids Patients With Long COVID

Cognitive behavioral therapy (CBT) and physical and mental health rehabilitation can help improve symptoms of long COVID, according to a review published online Nov. 27 in The BMJ.

Dena Zeraatkar, Ph.D., from McMaster University in Ontario, Canada, and colleagues conducted a systematic literature review to compare the effectiveness of interventions for the management of long COVID (post-COVID condition).

Based on 24 trials (3,695 patients), the researchers found moderate certainty evidence that when compared with usual care, an online program of CBT probably reduces fatigue (mean difference, −8.4) and probably improves concentration (mean difference, −5.2) in patients with long COVID. There was also moderate-certainty evidence that when compared with usual care, an online, supervised, combined physical and mental health rehabilitation program probably leads to improvement in overall health, with an estimated 161 more patients per 1,000 experiencing meaningful improvement or recovery. Moderate-certainty evidence also showed the online, supervised, combined program probably reduces symptoms of depression (mean difference, −1.50) and probably improves quality of life (0.04). Additionally, moderate-certainty evidence showed that intermittent aerobic exercise three to five times weekly for four to six weeks probably improves physical function versus continuous exercise. No compelling evidence was seen to support the effectiveness of vortioxetine, leronlimab, combined probiotics-prebiotics, coenzyme Q10, amygdala and insula retraining, combined L-arginine and vitamin C, inspiratory muscle training, transcranial direct current stimulation, or hyperbaric oxygen.

"We trust that this systematic review will inform future guideline recommendations about the care of patients with long COVID," the authors write.

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Exposures to Eight Factors Contribute to Increasing Trends in IHD, Stroke

Altered exposures to eight factors contribute to increasing trends in ischemic heart disease (IHD) and stroke on a global scale, according to a study published online Nov. 20 in PLOS Global Public Health.

Ruiqi Xia, from Fudan University School of Public Health in Shanghai, and colleagues extracted age-standardized incidence rates (ASIRs) of IHD and stroke and summary exposure values (SEVs) of 87 attributable factors to examine temporal trends and identify potential contributing factors.

The researchers found a declining trend for ASIRs of stroke and IHD (average annual percentage change, –0.64 and –0.67 percent). However, increases in the ASIR of IHD were seen in Eastern Sub-Saharan Africa, Western Sub-Saharan Africa, East Asia, Central Asia, and Oceania, especially in Uzbekistan and 55 other countries experiencing rapid socioeconomic translation. At the country level, eight factors were reversely associated with the ASIR of IHD and stroke, including diet high in trans-fatty acids, diet low in calcium, high body mass index, household air pollution from solid fuels, nonexclusive breastfeeding, occupational ergonomic factors, vitamin A deficiency, and occupational exposure to particulate matter, gases, and fumes. Significant reverse associations were seen for the factors with the ASIRs of IHD and stroke in Western Sub-Saharan Africa, East Asia, and Oceania.

"The findings indicate the contribution of the altered SEVs of the risk factors in the discrepant trends of IHD and stroke, and the determinant role of socioeconomic development in the changing patterns of the risk factors and the incidences of IHD and stroke," the authors write.

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President-Elect Trump Names His Picks to Head the CDC and FDA

President-elect Donald Trump has announced his picks for key health positions in his new cabinet.

To run the U.S. Centers for Disease Control and Prevention, Trump has turned to David Weldon, M.D., a long-time internist who interrupted his medical career to represent a Florida district for seven terms in the U.S. House of Representatives before returning to medical practice.

According to The New York Times, some of Weldon's opinions have been controversial, including endorsing the notion that thimerosal, a preservative used in some vaccines, is a cause of autism in children. That theory has long been discredited by science. In 2007, Weldon also sponsored a failed bill in Congress, which called for vaccine safety research to be conducted by a separate agency within the U.S. Department of Health and Human Services.

Trump has turned to Johns Hopkins School of Medicine pancreatic surgeon Martin Makary, M.D., to run the U.S. Food and Drug Administration. According to The Times, Makary is, on the whole, supportive of childhood vaccines, although he has voiced concern about certain shots, such as the hepatitis B vaccine for newborns and the need for a third COVID-19 booster for healthy children. He has also been a vocal critic of vaccine mandates, claiming instead that doctors underestimate the power of natural immunity in warding off disease.

Trump's pick to be the new surgeon general is Janette Nesheiwat, M.D. She is medical director of CityMD, a chain of urgent care centers, and a frequent Fox News contributor, according to The Times. She is on record as being generally supportive of COVID-19 vaccines, once telling Fox News that they were a "gift from God." But she has also voiced opposition to vaccine mandates.

Nesheiwat also sells her own line of vitamins and is the author of a forthcoming book, Beyond the Stethoscope: Miracles in Medicine, which the publisher notes discusses the "transformative power of prayer." She is also politically well connected: Her sister Julia Nesheiwat was homeland security adviser in the first Trump administration and is the wife of U.S. Rep. Michael Waltz, the Florida Republican who is Trump's pick for national security adviser.

The New York Times Article

Vitamin D Supplements May Lower Blood Pressure in Seniors With Overweight

Among older individuals with overweight, vitamin D supplementation coadministered with calcium reduces systolic and diastolic blood pressure (SBP and DBP), according to a study published online Nov. 12 in the Journal of the Endocrine Society.

Maya Rahme, from the American University of Beirut Medical Center, and colleagues examined the effect of two doses of cholecalciferol (vitamin D3) supplementation coadministered with calcium on SBP and DBP. Ambulatory, older adults with overweight (221) received a calcium dose and oral vitamin D3 at 600 or 3,750 IU/day equivalent.

The researchers found a significant decrease in SBP and DBP in the overall group and in the high-dose group at six and 12 months. Trends were similar in the low-dose group but did not reach statistical significance. SBP decreased significantly in both treatment groups among individuals with body mass index (BMI) >30 kg/m2, while a significant decrease in DBP was only seen in the high-dose group. In the subgroups of 143 participants with hypertension, there was a decrease in SBP and DBP at six and 12 months, independent of BMI levels and at both vitamin D levels. BMI and baseline SBP significantly predicted SBP at six and 12 months, but vitamin D treatment dose did not in multivariate linear mixed models with random effects in the overall group of participants.

"Our trial and critical synthesis of data from other relevant randomized controlled trials suggest a putative beneficial effect of vitamin D in older populations with inadequate vitamin D levels and hypertension," the authors write.

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Risk for Emergently Treated Hypocalcemia With Denosumab Rises With CKD Stage

For patients with chronic kidney disease (CKD), the risk for emergently treated hypocalcemia with denosumab increases with worsening CKD stage, according to a study published online Nov. 19 in the Annals of Internal Medicine.

Steven T. Bird, Ph.D., Pharm.D., from the U.S. Food and Drug Administration in Silver Spring, Maryland, and colleagues conducted a target trial emulation to examine the risk for emergently treated hypocalcemia with denosumab by stage of CKD and presence of CKD-mineral and bone disorder (MBD) among female patients aged 65 years or older. Participants initiated denosumab (361,453 patients), oral bisphosphonates (829,044 patients), or intravenous bisphosphonates (160,413 patients) for osteoporosis.

The researchers found that with denosumab versus oral bisphosphonates, the risk for emergently treated hypocalcemia increased with worsening CKD stage, with the highest risk seen among dialysis-dependent patients (3.01 versus 0.0 percent) and non-dialysis-dependent patients with CKD stages 4 and 5 (0.57 versus 0.03 percent). Among patients with stages 4 and 5 CKD, denosumab exhibited a higher risk for emergently treated hypocalcemia versus oral bisphosphonates in those with CKD-MBD (1.53 versus 0.02 percent) than in those without CKD-MBD (0.22 versus 0.03 percent). Increased risk was also seen for denosumab versus intravenous bisphosphonates.

"The highest incidence was seen in patients with advanced CKD and those with CKD-MBD," the authors write. "Diagnosis and management of skeletal fragility in these high-risk patients is complex, requiring careful patient selection, adequate supplementation with calcium and vitamin D, and frequent monitoring of serum calcium under supervision of a clinician with expert knowledge and experience treating CKD-MBD."

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Prenatal Vitamin D Supplementation Increases Bone Density in Children

Supplementation with cholecalciferol 1,000 IU/day during pregnancy is associated with greater offspring bone mineral density during childhood, according to a study published in the November issue of the American Journal of Clinical Nutrition.

Rebecca J. Moon, B.M., B.Sc., from the University of Southampton in the United Kingdom, and colleagues examined whether gestational vitamin D supplementation increases offspring bone mineral density at ages 6 to 7 years in a post-hoc analysis of the Maternal Vitamin D Osteoporosis Study randomized controlled trial. Pregnant women at <14 weeks of gestation with a singleton pregnancy and serum 25-hydroxyvitamin D of 25 to 100 nmol/L were randomly assigned to receive 1,000 IU/day cholecalciferol or placebo from 14 to 17 weeks of gestation until delivery. Offspring born to participants were invited to the childhood follow-up at ages 4 and 6 to 7 years. A total of 454 children were followed up at age 6 to 7 years; 447 had a usable dual-energy X-ray absorptiometry scan.

The researchers found that compared with placebo, gestational cholecalciferol supplementation resulted in significantly higher whole-body-less-head bone mineral content, bone mineral density, bone mineral apparent density, and lean mass. At ages 4 and 6 to 7 years, the effect of pregnancy cholecalciferol on bone outcomes was similar.

"This early intervention represents an important public health strategy," Moon said in a statement. "It strengthens children's bones and reduces the risk of conditions like osteoporosis and fractures in later life."

Several authors disclosed ties to pharmaceutical and nutrition companies, including Merck, which provided the supplement.

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