PMID 33237064 Effects of combined calcium and vitamin D supplementation on osteoporosis in postmenopausal women: a systematic review and meta-analysis of RCTs Meta-analysis · Food Funct, 2020 Combined calcium plus vitamin D raised bone density and reduced hip fractures in postmenopausal women (meta-analysisA statistical synthesis combining results of multiple studies into one conclusion.).
Key summary
A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s in postmenopausal women. Combined calcium and vitamin D significantly raised total, lumbar-spine, and femoral-neck bone mineral densityA measure of the mineral content of bone; lower values indicate weaker bones. (BMD) and lowered hip-fracture risk (RR 0.864). The improvement in femoral-neck BMD was clear only in the subgroup taking 400 IUInternational unit - a measure of a vitamin biological activity; for vitamin E, 1 IU is roughly 0.45 to 0.67 mg depending on the form./day of vitamin D or less. The conclusion is that combined supplementation can reduce osteoporotic hip fractures in postmenopausal women.
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OBJECTIVE: The aim of the present study was to explore whether combined calcium and vitamin D supplementation is beneficial for osteoporosis in postmenopausal women. METHODS: We searched the PubMed, Cochrane library, Web of science and Embase databases and reference lists of eligible articles up to Feb, 2020. Randomized controlled trials (RCTs) evaluating the effect of combined calcium and vitamin D on osteoporosis in postmenopausal women were included in the present study. RESULTS: Combined calcium and vitamin D significantly increased total bone mineral density (BMD) (standard mean differences (SMD) = 0.537; 95% confidence interval (CI): 0.227 to 0.847), lumbar spine BMD (SMD = 0.233; 95% CI: 0.073 to 0.392; P < 0.001), arms BMD (SMD = 0.464; 95% CI: 0.186 to 0.741) and femoral neck BMD (SMD = 0.187; 95% CI: 0.010 to 0.364). It also significantly reduced the incidence of hip fracture (RR = 0.864; 95% CI: 0.763 to 0.979). Subgroup analysis showed that combined calcium and vitamin D significantly increased femoral neck BMD only when the dose of the vitamin D intake was no more than 400 IU d-1 (SMD = 0.335; 95% CI: 0.113 to 0.558), but not for a dose more than 400 IU d-1 (SMD = -0.098; 95% CI: -0.109 to 0.305), and calcium had no effect on the femoral neck BMD. Subgroup analysis also showed only dairy products fortified with calcium and vitamin D had a significant influence on total BMD (SMD = 0.784; 95% CI: 0.322 to 1.247) and lumbar spine BMD (SMD = 0.320; 95% CI: 0.146 to 0.494), but not for combined calcium and vitamin D supplement. CONCLUSION: Dairy products fortified with calcium and vitamin D have a favorable effect on bone mineral density. Combined calcium and vitamin D supplementation could prevent osteoporosis hip fracture in postmenopausal women. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 35939577 Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults (VITAL) RCT · N Engl J Med, 2022 In healthy midlife and older adults who were not deficient, vitamin D3 alone did not reduce fractures (large RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.).
Key summary
A large randomized trial (VITAL) in 25,871 healthy midlife and older adults who were not selected for deficiency, low bone mass, or osteoporosis. Vitamin D3 supplementation did not significantly lower total fracture risk versus placeboAn inert dummy treatment used as the comparison baseline. (median follow-up 5.3 years). The finding is that there is no evidence that vitamin D alone prevents fractures in the general population.
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BACKGROUND: Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent. METHODS: In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether supplemental vitamin D3 would result in a lower risk of fractures than placebo. VITAL was a two-by-two factorial, randomized, controlled trial that investigated whether supplemental vitamin D3 (2000 IU per day), n-3 fatty acids (1 g per day), or both would prevent cancer and cardiovascular disease in men 50 years of age or older and women 55 years of age or older in the United States. Participants were not recruited on the basis of vitamin D deficiency, low bone mass, or osteoporosis. Incident fractures were reported by participants on annual questionnaires and adjudicated by centralized medical-record review. The primary end points were incident total, nonvertebral, and hip fractures. Proportional-hazards models were used to estimate the treatment effect in intention-to-treat analyses. RESULTS: Among 25,871 participants (50.6% women [13,085 of 25,871] and 20.2% Black [5106 of 25,304]), we confirmed 1991 incident fractures in 1551 participants over a median follow-up of 5.3 years. Supplemental vitamin D3, as compared with placebo, did not have a significant effect on total fractures (which occurred in 769 of 12,927 participants in the vitamin D group and in 782 of 12,944 participants in the placebo group; hazard ratio, 0.98; 95% confidence interval [CI], 0.89 to 1.08; P = 0.70), nonvertebral fractures (hazard ratio, 0.97; 95% CI, 0.87 to 1.07; P = 0.50), or hip fractures (hazard ratio, 1.01; 95% CI, 0.70 to 1.47; P = 0.96). There was no modification of the treatment effect according to baseline characteristics, including age, sex, race or ethnic group, body-mass index, or serum 25-hydroxyvitamin D levels. There were no substantial between-group differences in adverse events as assessed in the parent trial. CONCLUSIONS: Vitamin D3 supplementation did not result in a significantly lower risk of fractures than placebo among generally healthy midlife and older adults who were not selected for vitamin D deficiency, low bone mass, or osteoporosis. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; VITAL ClinicalTrials.gov number, NCT01704859.). ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 30675873 Vitamin D supplementation to prevent acute respiratory infections: individual participant data meta-analysis IPD meta-analysis · Health Technol Assess, 2019 Vitamin D supplementation slightly lowered the risk of acute respiratory infection - especially in the severely deficient (individual-participant-data meta-analysisA statistical synthesis combining results of multiple studies into one conclusion.).
Key summary
An individual-participant-data (IPD) meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of 25 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s and 11,321 participants. Vitamin D supplementation lowered the overall risk of acute respiratory infection (ARI) (adjusted odds ratio 0.88), with the benefit seen especially in people with very low 25(OH)DThe main form of vitamin D measured in blood to gauge vitamin D status. and in those given daily or weekly doses rather than one-off bolus doses. It was safe.
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BACKGROUND: Randomised controlled trials (RCTs) exploring the potential of vitamin D to prevent acute respiratory infections have yielded mixed results. Individual participant data (IPD) meta-analysis has the potential to identify factors that may explain this heterogeneity. OBJECTIVES: To assess the overall effect of vitamin D supplementation on the risk of acute respiratory infections (ARIs) and to identify factors modifying this effect. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, ClinicalTrials.gov and the International Standard Randomised Controlled Trials Number (ISRCTN) registry. STUDY SELECTION: Randomised, double-blind, placebo-controlled trials of supplementation with vitamin D3 or vitamin D2 of any duration having incidence of acute respiratory infection as a prespecified efficacy outcome were selected. STUDY APPRAISAL: Study quality was assessed using the Cochrane Collaboration Risk of Bias tool to assess sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, completeness of outcome data, evidence of selective outcome reporting and other potential threats to validity. RESULTS: We identified 25 eligible RCTs (a total of 11,321 participants, aged from 0 to 95 years). IPD were obtained for 10,933 out of 11,321 (96.6%) participants. Vitamin D supplementation reduced the risk of ARI among all participants [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.81 to 0.96; heterogeneity p < 0.001]. Subgroup analysis revealed that protective effects were seen in individuals receiving daily or weekly vitamin D without additional bolus doses (aOR 0.81, 95% CI 0.72 to 0.91), but not in those receiving one or more bolus doses (aOR 0.97, 95% CI 0.86 to 1.10; p = 0.05). Among those receiving daily or weekly vitamin D, protective effects of vitamin D were stronger in individuals with a baseline 25-hydroxyvitamin D [25(OH)D] concentration of < 25 nmol/l (aOR 0.30, 95% CI 0.17 to 0.53) than in those with a baseline 25(OH)D concentration of ≥ 25 nmol/l (aOR 0.75, 95% CI 0.60 to 0.95; p = 0.006). Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (aOR 0.98, 95% CI 0.80 to 1.20; p = 0.83). The body of evidence contributing to these analyses was assessed as being of high quality. LIMITATIONS: Our study had limited power to detect the effects of vitamin D supplementation on the risk of upper versus lower respiratory infection, analysed separately. CONCLUSIONS: Vitamin D supplementation was safe, and it protected against ARIs overall. Very deficient individuals and those not receiving bolus doses experienced the benefit. Incorporation of additional IPD from ongoing trials in the field has the potential to increase statistical power for analyses of secondary outcomes. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014013953. FUNDING: The National Institute for Health Research Health Technology Assessment programme. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 31405892 Association between vitamin D supplementation and mortality: systematic review and meta-analysis Meta-analysis · BMJ, 2019 Vitamin D alone did not reduce all-cause or cardiovascular mortality and lowered only cancer death, by about 16% (meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of 52 trials).
Key summary
A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of 52 trials and 75,454 participants. Vitamin D supplementation had no significant association with all-cause mortality (risk ratio 0.98) or cardiovascular death, but it lowered the risk of cancer death by 16%. The conclusion is that there is no evidence it reduces all-cause mortality.
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OBJECTIVE: To investigate whether vitamin D supplementation is associated with lower mortality in adults. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase, and the Cochrane Central Register from their inception to 26 December 2018. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing vitamin D supplementation with a placebo or no treatment for mortality were included. Independent data extraction was conducted and study quality assessed. A meta-analysis was carried out by using fixed effects and random effects models to calculate risk ratio of death in the group receiving vitamin D supplementation and the control group. MAIN OUTCOME MEASURES: All cause mortality. RESULTS: 52 trials with a total of 75 454 participants were identified. Vitamin D supplementation was not associated with all cause mortality (risk ratio 0.98, 95% confidence interval 0.95 to 1.02, I2=0%), cardiovascular mortality (0.98, 0.88 to 1.08, 0%), or non-cancer, non-cardiovascular mortality (1.05, 0.93 to 1.18, 0%). Vitamin D supplementation statistically significantly reduced the risk of cancer death (0.84, 0.74 to 0.95, 0%). In subgroup analyses, all cause mortality was significantly lower in trials with vitamin D3 supplementation than in trials with vitamin D2 supplementation (P for interaction=0.04); neither vitamin D3 nor vitamin D2 was associated with a statistically significant reduction in all cause mortality. CONCLUSIONS: Vitamin D supplementation alone was not associated with all cause mortality in adults compared with placebo or no treatment. Vitamin D supplementation reduced the risk of cancer death by 16%. Additional large clinical studies are needed to determine whether vitamin D3 supplementation is associated with lower all cause mortality. STUDY REGISTRATION: PROSPERO registration number CRD42018117823. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 37380191 Vitamin D supplementation and major cardiovascular events: D-Health randomised controlled trial RCT · BMJ, 2023 Vitamin D might slightly reduce major cardiovascular events, but the absolute difference is small and compatible with no effect (large RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.).
Key summary
A large randomized trial (D-Health) in 21,302 adults aged 60–84 given a high monthly dose, with a median of 5 years. The rate of major cardiovascular events was lower in the vitamin D group than in the placeboAn inert dummy treatment used as the comparison baseline. group, but the absolute risk difference was small and the confidence interval was also compatible with no effect. The finding is that a cardiovascular-prevention effect is uncertain.
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OBJECTIVE: To investigate whether supplementing older adults with monthly doses of vitamin D alters the incidence of major cardiovascular events. DESIGN: Randomised, double blind, placebo controlled trial of monthly vitamin D (the D-Health Trial). Computer generated permuted block randomisation was used to allocate treatments. SETTING: Australia from 2014 to 2020. PARTICIPANTS: 21 315 participants aged 60-84 years at enrolment. Exclusion criteria were self-reported hypercalcaemia, hyperparathyroidism, kidney stones, osteomalacia, sarcoidosis, taking >500 IU/day supplemental vitamin D, or unable to give consent because of language or cognitive impairment. INTERVENTION: 60 000 IU/month vitamin D3 (n=10 662) or placebo (n=10 653) taken orally for up to five years. 16 882 participants completed the intervention period: placebo 8270 (77.6%); vitamin D 8552 (80.2%). MAIN OUTCOME MEASURES: The main outcome for this analysis was the occurrence of a major cardiovascular event, including myocardial infarction, stroke, and coronary revascularisation, determined through linkage with administrative datasets. Each event was analysed separately as secondary outcomes. Flexible parametric survival models were used to estimate hazard ratios and 95% confidence intervals. RESULTS: 21 302 people were included in the analysis. The median intervention period was five years. 1336 participants experienced a major cardiovascular event (placebo 699 (6.6%); vitamin D 637 (6.0%)). The rate of major cardiovascular events was lower in the vitamin D group than in the placebo group (hazard ratio 0.91, 95% confidence interval 0.81 to 1.01), especially among those who were taking cardiovascular drugs at baseline (0.84, 0.74 to 0.97; P for interaction=0.12), although the P value for interaction was not significant (<0.05). Overall, the difference in standardised cause specific cumulative incidence at five years was -5.8 events per 1000 participants (95% confidence interval -12.2 to 0.5 per 1000 participants), resulting in a number needed to treat to avoid one major cardiovascular event of 172. The rate of myocardial infarction (hazard ratio 0.81, 95% confidence interval 0.67 to 0.98) and coronary revascularisation (0.89, 0.78 to 1.01) was lower in the vitamin D group, but there was no difference in the rate of stroke (0.99, 0.80 to 1.23). CONCLUSIONS: Vitamin D supplementation might reduce the incidence of major cardiovascular events, although the absolute risk difference was small and the confidence interval was consistent with a null finding. These findings could prompt further evaluation of the role of vitamin D supplementation, particularly in people taking drugs for prevention or treatment of cardiovascular disease. TRIAL REGISTRATION: ACTRN12613000743763. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 22456619 Comparison of vitamin D2 and vitamin D3 supplementation in raising serum 25-hydroxyvitamin D RCT · J Clin Endocrinol Metab, 2012 Vitamin D3 (2,000 IUInternational unit - a measure of a vitamin biological activity; for vitamin E, 1 IU is roughly 0.45 to 0.67 mg depending on the form./day) and D2 (50,000 IU/week) raised blood 25(OH)DThe main form of vitamin D measured in blood to gauge vitamin D status. more than D2 (2,000 IU/day) (RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.).
Key summary
A randomized trial in children and adolescents with IBD. Over 6 weeks, vitamin D3 2,000 IUInternational unit - a measure of a vitamin biological activity; for vitamin E, 1 IU is roughly 0.45 to 0.67 mg depending on the form./day and D2 50,000 IU/week raised blood 25(OH)DThe main form of vitamin D measured in blood to gauge vitamin D status. more than D2 2,000 IU/day, and were well tolerated with no hypercalcemiaAbnormally high calcium in the blood.. It shows that the rise in blood levels differs by form and dose.
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CONTEXT: Vitamin D insufficiency [serum 25-hydroxyvitamin D (25OHD) concentration less than 20 ng/ml] is prevalent among children with inflammatory bowel disease (IBD), and its treatment has not been studied. OBJECTIVE: The aim of this study was to compare the efficacy and safety of three vitamin D repletion regimens. DESIGN AND SETTING: We conducted a randomized, controlled clinical trial from November 2007 to June 2010 at the Clinical and Translational Study Unit of Children's Hospital Boston. The study was not blinded to participants and investigators. PATIENTS: Eligibility criteria included diagnosis of IBD, age 5-21, and serum 25OHD concentration below 20 ng/ml. Seventy-one patients enrolled, 61 completed the trial, and two withdrew due to adverse events. INTERVENTION: Patients received orally for 6 wk: vitamin D(2), 2,000 IU daily (arm A, control); vitamin D(3), 2,000 IU daily (arm B); vitamin D(2), 50,000 IU weekly (arm C); and an age-appropriate calcium supplement. MAIN OUTCOME MEASURE: We measured the change in serum 25OHD concentration (Δ25OHD) (ng/ml). Secondary outcomes included change in serum intact PTH concentration (ΔPTH) (pg/ml) and the adverse event occurrence rate. RESULTS: After 6 wk, Δ25OHD ± se was: 9.3 ± 1.8 (arm A); 16.4 ± 2.0 (arm B); 25.4 ± 2.5 (arm C); P (A vs. C) = 0.0004; P (A vs. B) = 0.03. ΔPTH ± SE was -5.6 ± 5.5 (arm A); -0.1 ± 4.2 (arm B); -4.4 ± 3.9 (arm C); P = 0.57. No participant experienced hypercalcemia or hyperphosphatemia, and the prevalence of hypercalciuria did not differ among arms at follow-up. CONCLUSIONS: Oral doses of 2,000 IU vitamin D(3) daily and 50,000 IU vitamin D(2) weekly for 6 wk are superior to 2,000 IU vitamin D(2) daily for 6 wk in raising serum 25OHD concentration and are well-tolerated among children and adolescents with IBD. The change in serum PTH concentration did not differ among arms. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ FDA (DailyMed) Ergocalciferol (vitamin D2) - prescription drug label (warnings and interactions)
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View original ↗ USDA FoodData Central Fish, trout, rainbow, farmed, cooked, dry heat (FDC 173718)
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View original ↗ USDA FoodData Central Fish, salmon, Atlantic, farmed, cooked, dry heat (FDC 175168)
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View original ↗ USDA FoodData Central Fish, salmon, sockeye, cooked, dry heat (FDC 173692)
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View original ↗ USDA FoodData Central Fish, sardine, Atlantic, canned in oil, drained solids with bone (FDC 175139)
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View original ↗ USDA FoodData Central Milk, whole, 3.25% milkfat, with added vitamin D (FDC 746782)
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View original ↗ USDA FoodData Central Egg, whole, cooked, hard-boiled (FDC 173424)
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View original ↗ USDA FoodData Central Mushrooms, portabella, exposed to ultraviolet light, grilled (FDC 169377)
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