scholarly journals VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population

2020 ◽  
Vol 105 (9) ◽  
pp. 2929-2938 ◽  
Author(s):  
Meryl S LeBoff ◽  
Elle M Murata ◽  
Nancy R Cook ◽  
Peggy Cawthon ◽  
Sharon H Chou ◽  
...  
Keyword(s):  
Vitamin D ◽  
Outcome Measures ◽  
Vitamin D3 ◽  
Fall Risk ◽  
Omega 3 ◽  
Hospital Visit ◽  
Baseline Serum ◽  
The Us ◽  
Supplemental Vitamin ◽  
Risk Of Falls

Abstract Context It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting. Objective The objective of this work is to determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk. Design VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25 871 adults, randomly assigned November 2011 to March 2014 and treated for 5.3 years (median). Setting This is a nationwide study. Participants Men 50 years or older and women 55 years or older (mean age, 67.1 years) without cancer or cardiovascular disease at baseline participated in this study. Interventions Interventions included vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2 × 2 factorial design. Main Outcome Measures Main outcome measures include 2 or more falls and falls resulting in a doctor or hospital visit. Results Baseline serum total 25-hydroxyvitamin D (25[OH]D) level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with 2 or more falls were similar between active and placebo groups (9.8% vs 9.4%). Over 5 years, there were no differences in the proportion having 2 or more falls (odds ratio [OR] = 0.97; 95% CI, 0.90-1.05, P = .50), falls resulting in a doctor visit (OR = 1.03; 95% CI, 0.94-1.13, P = .46), or resulting in a hospital visit (OR = 1.04; 95% CI, 0.90-1.19, P = .61) between groups. Results did not differ between those with baseline 25(OH)D less than 50 vs 50 nmol/L or greater or other cut points. Conclusion Daily supplemental vitamin D3 vs placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the US population.

scholarly journals Effects of Vitamin D3 Supplementation on Body Composition in the VITamin D and OmegA-3 TriaL (VITAL)

2021 ◽  
Author(s):  
Sharon H Chou ◽  
Elle M Murata ◽  
Cindy Yu ◽  
Jacqueline Danik ◽  
Gregory Kotler ◽  
...  
Keyword(s):  
Vitamin D ◽  
Body Composition ◽  
Vitamin D3 ◽  
Omega 3 ◽  
Fat Percentage ◽  
Science Center ◽  
Lean Tissue ◽  
Hydroxyvitamin D ◽  
Supplemental Vitamin ◽  
Vitamin D3 Supplementation

Abstract Context Although observational studies show inverse associations between vitamin D status and body weight/adiposity, there are few large randomized controlled trials (RCTs) investigating this relationship. Objective To determine whether vitamin D3 supplementation lowers weight or improves body composition. Design The VITamin D and OmegA-3 TriaL (VITAL) was a double-blinded, placebo-controlled RCT including 25,871 U.S. adults. This ancillary study was completed in a sub-cohort that underwent body composition assessments at baseline and 2-year follow-up (89% retention). Setting Harvard Clinical and Translational Science Center in Boston Participants 771 participants (men ≥50 and women ≥55 years) Interventions 2x2 factorial design of supplemental vitamin D3 (2000 IU/day) and/or omega-3 fatty acids (1 g/day) Main Outcome Measures Endpoints were 2-year changes in weight, body mass index (BMI), waist circumference, and total and/or regional fat and lean tissue measures determined by dual-energy X-ray absorptiometry. Effect modification by clinical variables and total and free 25-hydroxyvitamin D (25[OH]D) levels was explored. Results There were no effects of supplemental vitamin D3 versus placebo on weight, BMI, or measures of adiposity and lean tissue. Effects did not vary by sex, race/ethnicity, fat mass index, or baseline total or free 25(OH)D levels. Vitamin D3 supplementation did slightly improve body fat percentage in participants with normal BMI at baseline, but not in the overweight or obese (p for interaction=0.04). Conclusions Daily vitamin D3 supplementation versus placebo in the general older population did not improve weight or body composition. Whether supplemental vitamin D3 may benefit individuals with normal BMI warrants further study.

scholarly journals Design and Main Results of STURDY: A Randomized Clinical Trial of Four Vitamin D3 Doses to Prevent Falls in Older Adults

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 759-759
Author(s):  
Lawrence Appel ◽  
Jennifer Schrack ◽  
Erin Michos ◽  
Christine Mitchell ◽  
Stephen Juraschek ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Primary Outcome ◽  
Vitamin D Supplementation ◽  
Dose Finding ◽  
High Dose ◽  
Hazard Ratios ◽  
Risk Of Falls ◽  
Event Rates ◽  
And Control

Abstract STURDY was a Bayesian, response-adaptive trial with dose-finding and confirmatory stages. Participants (n=688; ≥70years with serum 25(OH)D of 10-29ng/mL) were randomized to 200 (control), 1000, 2000, or 4000 IU/day of vitamin D3. The primary outcome was time to first fall or death over 2 years. During dose-finding, the best non-control dose was determined to be 1000IU/day based on higher primary outcome event rates in the 2000 and 4000IU/day doses than the 1000IU/day dose (posterior probability of being best dose=0.90; hazard ratios[HR] were 1.86 [95%CI: 1.16-2.97] and 1.68 [95%CI: 1.05-2.69], respectively). Participants were then switched from other non-control doses to 1000IU/day, and event rates did not differ between the pooled higher doses and control groups (HR=1.02, P=0.84). There was no heterogeneity by baseline 25(OHD). In conclusion, high-dose vitamin D supplementation ≥1000IU/day did not prevent falls. Whether vitamin D doses >2000IU/day increase the risk of falls is uncertain.

Abstract 49: Supine Versus Seated Positions On The Detection Of Orthostatic Hypotension And Its Association With Fall Risk And Orthostatic Symptoms

Hypertension ◽  
2021 ◽  
Vol 78 (Suppl_1) ◽  
Author(s):  
Stephen P Juraschek ◽  
Lawrence J Appel ◽  
Edgar R Miller
Keyword(s):  
Blood Pressure ◽  
Vitamin D ◽  
Orthostatic Hypotension ◽  
Fall Risk ◽  
Ad Hoc ◽  
The Past ◽  
Trial Testing ◽  
Risk Of Falls ◽  
Orthostatic Symptoms ◽  
The Impact

Background: Hypertension trials that monitor orthostatic hypotension (OH) compare standing to seated blood pressure (BP) rather than supine BP. We determined the impact of a supine vs seated position on OH prevalence and its relationship with fall risk and orthostatic symptoms. Methods: The Study to Understand Fall Reduction and Vitamin D in You (STURDY) was a randomized trial testing the effects of vitamin D3 dose on falls in adults age ≥70 years at higher risk of falls. OH was determined at baseline, 3, 12, and 24 months with each of 2 protocols: (1) seated to standing and (2) supine to standing. OH was defined as a drop in systolic or diastolic BP of at least 20 or 10 mm Hg. Participants were asked about orthostatic symptoms in the past month. Falls were ascertained via daily fall calendar, ad hoc reporting, and scheduled interviews. Results: Among 522 participants with 953 OH assessments (mean age 76 ± 5 years, 42% women, 18% Black), mean baseline BP was 129 ± 18/68 ± 11 mm Hg. Mean BP increased 3.4/2.6 mm Hg after sitting, but decreased -3.7/-0.7 mm Hg after being supine. OH was detected in 2.2% of seated vs 14.8% of supine assessments. Supine OH better predicted falls (HR 1.60; 95% CI: 0.98, 2.61; P =0.06) than seated OH (HR 0.70; 95% CI: 0.30, 1.60; P =0.39), although both were non-significant ( Figure ). While seated OH was not associated with orthostatic symptoms, supine OH was associated with a greater risk of fainting, blacking out, seeing spots, room spinning, and headache in the prior month ( P -values of 0.048 to 0.002). Conclusions: Supine OH was more prevalent and appeared to better predict falls and orthostatic symptoms than seated OH. These findings support a supine protocol for OH in clinical practice.

scholarly journals Effect of Vitamin D3 (Cholecalciferol) Supplementation on Serum Vitamin D3 and 25-hydroxyvitamin D (25(OH)D) Concentrations Among Participants in the VITAL-DKD Study

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1779-1779
Author(s):  
Cora Best ◽  
Leila Zelnick ◽  
Simon Hsu ◽  
Christine Limonte ◽  
Ravi Thadhani ◽  
...  
Keyword(s):  
Vitamin D ◽  
Body Weight ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Serum Vitamin ◽  
Threshold Effect ◽  
Omega 3 ◽  
Serum Vitamin D ◽  
Supplement Use ◽  
Effect Of Treatment

Abstract Objectives To compare the serum vitamin D3 and 25(OH)D responses to vitamin D3 supplementation in the VITAL-DKD study. Methods The Vitamin D and OmegA-3 TriaL (VITAL)-DKD was a 2 × 2 factorial, randomized, placebo-controlled trial of vitamin D3 (2000 IU/day) and omega-3 fatty acids (1 g/day) for prevention of chronic kidney disease among adults with type 2 diabetes. For the first 200 enrolled participants, we measured baseline and year 2 serum vitamin D3 concentration with a new validated liquid chromatography-tandem mass spectrometry method. Linear regression was used to test the effects of D3 treatment on changes in serum D3 and 25(OH)D concentrations and to examine possible effect modification by relevant clinical characteristics. Results Participants were 70 ± 6 years of age, 64% male, 70% non-Hispanic white, and 15% black. At baseline and year 2, serum D3 concentration and 25(OH)D3 concentration were positively related, with a threshold effect at a 25(OH)D3 concentration of 50 nmol/L. Below this threshold, serum D3 concentration rarely exceeded 5 nmol/L. Above it, serum D3 concentration was much more variable. Supplementation increased mean serum D3 concentration from 12 nmol/L at baseline to 41 nmol/L at year 2 (difference compared with placebo 30 nmol/L; 95% CI 25 to 35 nmol/L) and increased mean serum 25(OH)D concentration from 76 nmol/L to 102 nmol/L (difference compared with placebo 33 nmol/L; 95% CI 26 to 40 nmol/L). The effect of treatment on change in serum 25(OH)D was modified by body weight (−0.48 nmol/L per kg of weight; P < 0.01), baseline 25(OH)D concentration (−0.30 nmol/L per nmol/L of baseline 25(OH)D; P < 0.01), baseline D3 concentration (−5 nmol/L per 100% increase in baseline D3; P = 0.04), and non-study vitamin D supplement use (smaller effect as dose of non-study supplement increased). The effect of treatment on change in serum D3 concentration was modified only by body weight (−0.33 nmol/L per kg of weight; P = 0.01). Conclusions Among older adults, 2 years of 2000 IU/day vitamin D3 led to similar mean increases in serum D3 and 25(OH)D. Unlike the serum 25(OH)D response, the serum D3 response to supplementation did not depend on baseline vitamin D status. The serum vitamin D concentration may be an additional, valuable marker of exposure to vitamin D during supplementation. Funding Sources NIDDK NIH ODS NHLBI.

scholarly journals Differentiated approach to correcting low vitamin D status in adolescent girls in Moscow

2021 ◽  
pp. 256-263
Author(s):  
I. N. Zakharova ◽  
E. A. Soloveva ◽  
T. M. Tvorogova ◽  
N. G. Sugian
Keyword(s):  
Vitamin D ◽  
Adolescent Girls ◽  
Vitamin D3 ◽  
Main Group ◽  
Control Group ◽  
Vitamin D Status ◽  
Double Blind ◽  
Study Objective ◽  
Baseline Serum ◽  
Randomized Clinical Study

Introduction. The work is devoted to the study of vitamin D status in adolescent girls and the selection of adequate doses for its correction.Study objective. To study the dynamics of calcidiol concentration in the blood serum against vitamin D3 intake and evaluate the effectiveness of correcting doses of vitamin in adolescent girls from Moscow.Study design. A double-blind, placebo-controlled, prospective, randomized clinical study.Materials and methods. The study involved adolescent girls aged from 11 to 17 years (n = 218) from I-II health groups, with determined serum level of 25(OH)D. Participants were randomly assigned to the main and control groups. The adolescent girls in the study group received vitamin D3 tablets, and the control group received a placebo. Study duration was 6 months. The dose of vitamin D3 was dependent on baseline serum caLcidioL levels and ranged from 800 IU to 2000 IU. Vitamin D status was redetermined in the girls who completed the treatment (n = 192).Results. Initially, 96.4% of girls had a low vitamin D status, while vitamin D insufficiency was observed in 26.6%, deficiency in 57.8%, deep deficiency in 12%. The median level of 25(OH)D in the main group before taking the vitamin was 16.25 ng/ml, after taking - 24.1            ng/ml, in the control group - 17.9 and 11.4 ng/ml, respectively (p < 0.001). In the main group, an increase in the content of the metabolite was observed in 94.9% of the subjects, the initially identified pronounced deficit was completely absent.Conclusions. A differentiated approach to prescribing different doses of cholecalciferon, depending on the baseline level of 25(OH)D, BMI and age, is an effective method for replenishing vitamin D deficiency in adolescents. The high probability of normalization of vitamin D status in certain age groups, mainly with the appointment of low corrective doses of cholecalciferol justifies the possibility of their use for 6 months or more in adolescents during puberty period.

scholarly journals Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA‐3 TriaL (VITAL)

2020 ◽  
Vol 35 (5) ◽  
pp. 883-893 ◽  
Author(s):  
Meryl S LeBoff ◽  
Sharon H Chou ◽  
Elle M Murata ◽  
Catherine M Donlon ◽  
Nancy R Cook ◽  
...  
Keyword(s):  
Vitamin D ◽  
Health Outcomes ◽  
Bone Health ◽  
Omega 3 ◽  
Supplemental Vitamin

scholarly journals Vitamin D Supplementation on Detailed Fall Characteristics

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 759-759
Author(s):  
Amal Wanigatunga ◽  
Alice Sternberg ◽  
Amanda Blackford ◽  
Yurun Cai ◽  
Jennifer Schrack ◽  
...  
Keyword(s):  
Older Adults ◽  
Vitamin D ◽  
Vitamin D3 ◽  
Fall Risk ◽  
Rate Ratio ◽  
Vitamin D Supplementation ◽  
Trial Data ◽  
Fall Rates ◽  
To Receive

Abstract Evidence suggests Vitamin D supplementation may reduce fall risk in older adults, but effects on fall location and severity are less well described. We used STURDY trial data to examine whether Vitamin D supplementation reduces indoor, outdoor, “consequential” (falls resulting in injury or medical care), and repeat fall risk. Participants (77[SD=5.4] years; 44% women) were randomized to receive 200 (n=339) or 1000IU/day (n=349) of vitamin D3. Indoor, outdoor and consequential fall rates were similar between the ≥1000IU/day and 200IU/day groups (rate ratio [RR]:1.22, 95%CI:0.96-1.55; RR:0.85, 95%CI:0.65-1.10; and RR:1.16, 95%CI:0.93-1.45, respectively) during follow-up. The proportion of repeat fallers was similar between ≥1000IU/day versus 200IU/day groups over 3 months (7.8%[27/346] versus 6.5%[22/336], p=0.22), 6 months (18.8%(60/319) versus 16.2%(51/315), p=0.40), 12 months (29.9%(81/271) versus 31.2%(84/269), p=0.78) and 24 months (48.2%(66/137) versus 49.6%(66/133), p=0.90). In conclusion, Vitamin D supplementation ≥1000IU/day did not reduce indoor, outdoor, consequential or repeat fall risk.

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