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

The Journal of clinical endocrinology and metabolism
January 1, 1970
Meryl S LeBoff et al. (9 authors)
Journal ArticleRandomized Controlled TrialResearch Support, N.I.H., ExtramuralHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate whether daily supplementation with omega-3 fatty acids (1 g/day) affects fall risk in generally healthy older adults.

Results Summary

The abstract does not report specific results for omega-3 fatty acids, focusing instead on vitamin D3 supplementation, which showed no significant effect on fall risk.

Population

Men aged 50+ and women aged 55+ without cancer or cardiovascular disease at baseline (mean age: 67.1 years).

Effective Dosage

1 g/day

Duration

5.3 years (median)

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
vitamin D3 (cholecalciferol; 2000 IU/day)
no change
fall risk
generally healthy adults not selected for vitamin D insufficiency
-
did not decrease
#1
vitamin D3 (cholecalciferol; 2000 IU/day)
no change
2 or more falls
adults (men 50 years or older and women 55 years or older without cancer or cardiovascular disease)
9.8% vs 9.4%
were similar
#2
vitamin D3 (cholecalciferol; 2000 IU/day)
no change
2 or more falls
adults (men 50 years or older and women 55 years or older without cancer or cardiovascular disease)
OR = 0.97; 95% CI, 0.90-1.05, P = .50
no differences
#3
vitamin D3 (cholecalciferol; 2000 IU/day)
no change
falls resulting in a doctor visit
adults (men 50 years or older and women 55 years or older without cancer or cardiovascular disease)
OR = 1.03; 95% CI, 0.94-1.13, P = .46
no differences
#4
vitamin D3 (cholecalciferol; 2000 IU/day)
no change
falls resulting in a hospital visit
adults (men 50 years or older and women 55 years or older without cancer or cardiovascular disease)
OR = 1.04; 95% CI, 0.90-1.19, P = .61
no differences
#5
supplemental vitamin D
no change
primary prevention of falls
the US population
-
does not indicate that should be used
#6
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.

Medical Subject Headings (MeSH)
Accidental FallsAgedDietary SupplementsDouble-Blind MethodFatty Acids, Omega-3FemaleFractures, BoneHumansMaleMiddle AgedPrimary PreventionRisk FactorsTreatment OutcomeUnited StatesVitamin D
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Citation Metrics
Total Citations63
Citations/Year12.6
Relative Citation Ratio4.78
NIH Percentile92.5%
Research Impact Scores
APT Score0.95
Weight Score1.96
Normalized Score0.57
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