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Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study : A Randomized Clinical Trial.

Abstract

Importance

Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D.

Objective

To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population.

Design, Setting, and Participants

The Vitamin D Assessment Study is a randomized, double-blind, placebo-controlled trial that recruited participants mostly from family practices in Auckland, New Zealand, from April 5, 2011, through November 6, 2012, with follow-up until July 2015. Participants were community-resident adults aged 50 to 84 years. Of 47 905 adults invited from family practices and 163 from community groups, 5110 participants were randomized to receive vitamin D3 (n = 2558) or placebo (n = 2552). Two participants retracted consent, and all others (n = 5108) were included in the primary analysis.

Interventions

Oral vitamin D3 in an initial dose of 200 000 IU, followed a month later by monthly doses of 100 000 IU, or placebo for a median of 3.3 years (range, 2.5-4.2 years).

Main Outcomes and Measures

The primary outcome was the number of participants with incident CVD and death, including a prespecified subgroup analysis in participants with vitamin D deficiency (baseline deseasonalized 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Secondary outcomes were myocardial infarction, angina, heart failure, hypertension, arrhythmias, arteriosclerosis, stroke, and venous thrombosis.

Results

Of the 5108 participants included in the analysis, the mean (SD) age was 65.9 (8.3) years, 2969 (58.1%) were male, and 4253 (83.3%) were of European or other ethnicity, with the remainder being Polynesian or South Asian. Mean (SD) baseline deseasonalized 25(OH)D concentration was 26.5 (9.0) ng/mL, with 1270 participants (24.9%) being vitamin D deficient. In a random sample of 438 participants, the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group. The primary outcome of CVD occurred in 303 participants (11.8%) in the vitamin D group and 293 participants (11.5%) in the placebo group, yielding an adjusted hazard ratio of 1.02 (95% CI, 0.87-1.20). Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes.

Conclusions and Relevance

Monthly high-dose vitamin D supplementation does not prevent CVD. This result does not support the use of monthly vitamin D supplementation for this purpose. The effects of daily or weekly dosing require further study.

Trial Registration

clinicaltrials.gov Identifier: ACTRN12611000402943.

Links

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  • Authors+Show Affiliations

    ,

    School of Population Health, The University of Auckland, Auckland, New Zealand.

    ,

    School of Population Health, The University of Auckland, Auckland, New Zealand.

    ,

    School of Population Health, The University of Auckland, Auckland, New Zealand.

    ,

    School of Population Health, The University of Auckland, Auckland, New Zealand.

    ,

    Department of Public Health & General Practice, The University of Otago, Christchurch, New Zealand.

    ,

    School of Population Health, The University of Auckland, Auckland, New Zealand.

    ,

    School of Population Health, The University of Auckland, Auckland, New Zealand.

    ,

    Department of Public Health, University of Cambridge, Cambridge, England.

    Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston.

    Source

    JAMA cardiology 2:6 2017 06 01 pg 608-616

    MeSH

    Aged
    Aged, 80 and over
    Angina Pectoris
    Arrhythmias, Cardiac
    Arteriosclerosis
    Cardiovascular Diseases
    Cholecalciferol
    Dietary Supplements
    Double-Blind Method
    Female
    Heart Failure
    Humans
    Hypertension
    Male
    Middle Aged
    Myocardial Infarction
    New Zealand
    Proportional Hazards Models
    Stroke
    Venous Thrombosis
    Vitamin D Deficiency
    Vitamins

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    28384800

    Citation

    Scragg, Robert, et al. "Effect of Monthly High-Dose Vitamin D Supplementation On Cardiovascular Disease in the Vitamin D Assessment Study : a Randomized Clinical Trial." JAMA Cardiology, vol. 2, no. 6, 2017, pp. 608-616.
    Scragg R, Stewart AW, Waayer D, et al. Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study : A Randomized Clinical Trial. JAMA Cardiol. 2017;2(6):608-616.
    Scragg, R., Stewart, A. W., Waayer, D., Lawes, C. M. M., Toop, L., Sluyter, J., ... Camargo, C. A. (2017). Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study : A Randomized Clinical Trial. JAMA Cardiology, 2(6), pp. 608-616. doi:10.1001/jamacardio.2017.0175.
    Scragg R, et al. Effect of Monthly High-Dose Vitamin D Supplementation On Cardiovascular Disease in the Vitamin D Assessment Study : a Randomized Clinical Trial. JAMA Cardiol. 2017 06 1;2(6):608-616. PubMed PMID: 28384800.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study : A Randomized Clinical Trial. AU - Scragg,Robert, AU - Stewart,Alistair W, AU - Waayer,Debbie, AU - Lawes,Carlene M M, AU - Toop,Les, AU - Sluyter,John, AU - Murphy,Judy, AU - Khaw,Kay-Tee, AU - Camargo,Carlos A,Jr PY - 2017/4/7/pubmed PY - 2019/6/4/medline PY - 2017/4/7/entrez SP - 608 EP - 616 JF - JAMA cardiology JO - JAMA Cardiol VL - 2 IS - 6 N2 - Importance: Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D. Objective: To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population. Design, Setting, and Participants: The Vitamin D Assessment Study is a randomized, double-blind, placebo-controlled trial that recruited participants mostly from family practices in Auckland, New Zealand, from April 5, 2011, through November 6, 2012, with follow-up until July 2015. Participants were community-resident adults aged 50 to 84 years. Of 47 905 adults invited from family practices and 163 from community groups, 5110 participants were randomized to receive vitamin D3 (n = 2558) or placebo (n = 2552). Two participants retracted consent, and all others (n = 5108) were included in the primary analysis. Interventions: Oral vitamin D3 in an initial dose of 200 000 IU, followed a month later by monthly doses of 100 000 IU, or placebo for a median of 3.3 years (range, 2.5-4.2 years). Main Outcomes and Measures: The primary outcome was the number of participants with incident CVD and death, including a prespecified subgroup analysis in participants with vitamin D deficiency (baseline deseasonalized 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Secondary outcomes were myocardial infarction, angina, heart failure, hypertension, arrhythmias, arteriosclerosis, stroke, and venous thrombosis. Results: Of the 5108 participants included in the analysis, the mean (SD) age was 65.9 (8.3) years, 2969 (58.1%) were male, and 4253 (83.3%) were of European or other ethnicity, with the remainder being Polynesian or South Asian. Mean (SD) baseline deseasonalized 25(OH)D concentration was 26.5 (9.0) ng/mL, with 1270 participants (24.9%) being vitamin D deficient. In a random sample of 438 participants, the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group. The primary outcome of CVD occurred in 303 participants (11.8%) in the vitamin D group and 293 participants (11.5%) in the placebo group, yielding an adjusted hazard ratio of 1.02 (95% CI, 0.87-1.20). Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes. Conclusions and Relevance: Monthly high-dose vitamin D supplementation does not prevent CVD. This result does not support the use of monthly vitamin D supplementation for this purpose. The effects of daily or weekly dosing require further study. Trial Registration: clinicaltrials.gov Identifier: ACTRN12611000402943. SN - 2380-6591 UR - https://www.unboundmedicine.com/medline/citation/28384800/Effect_of_Monthly_High_Dose_Vitamin_D_Supplementation_on_Cardiovascular_Disease_in_the_Vitamin_D_Assessment_Study_:_A_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jamacardiology/fullarticle/10.1001/jamacardio.2017.0175 DB - PRIME DP - Unbound Medicine ER -