Overview

This trial is active, not recruiting.

Conditions vitamin d deficiency, vitamin; excess vitamin d (nutritional)
Sponsor VU University Medical Center
Collaborator European Union
Start date April 2015
End date August 2016
Trial size 2945 participants
Trial identifier NCT02551835, ODIN 8.3

Summary

This meta-analysis will be conducted to study the effect on vitamin D supplements on markers for cardiovascular disease and diabetes using individual participant data from 12 RCTs. Given that previous data suggest that vitamin D supplementation might be most effective in those individuals with very low 25-hydroxyvitamin D (25(OH)D) and potentially harmful in those achieving very high levels after vitamin D supplementation, this meta-analyses will be performed in subgroups according 25(OH)D levels.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
RCT on 20000 IU vitamin D3/week versus placebo for 1 year among persons with impaired glucose tolerance and/or impaired fasting glucose.
RCT on 20000 or 40000 IU vitamin D3/week plus 500 mg calcium/day versus placebo plus 500 mg calcium/day for 1 year among persons with a high body mass index.
RCT on 40000 IU vitamin D3/week plus 800 IU/day and 1000 mg calcium/day versus placebo plus 800 IU/day and 1000 mg calcium/day for 1 year among women with a low bone mineral density.
RCT on 40000 IU vitamin D3/week versus placebo for 6 months among persons with 25(OH)D values <42 nmol/L.
RCT on 40000 IU vitamin D3/week versus placebo for 6 months among persons with 25(OH)D values <55 nmol/L.
RCT on 2800 IU vitamin D3/day versus placebo for 8 weeks among persons a history of arterial hypertension and 25(OH)D values <75 nmol/L.
RCT on 7000 IU vitamin D3/day versus placebo for 6 months among persons with a high body mass index and 25(OH)D values <50 nmol/L.
RCT on 1200 IU vitamin D3/day plus 500 mg calcium/day versus placebo plus 500 mg calcium/day for 16 weeks among non-western immigrants with pre-diabetes and 25(OH)D values <50 nmol/L.
RCT on 600 IU vitamin D3/day (or daily equivalent) versus placebo for 4 months among nursing home residents >70 years of age.
RCT on 800 IU vitamin D3/day versus 100,000 IU/3 months versus sunlight advice for 6 months among non-western immigrants with 25(OH)D values <25 nmol/L.
RCT on 200, 400, or 600 IU vitamin D3/day versus placebo for 22 weeks among persons > 63 years of age.
RCT on 200, 400, or 600 IU vitamin D3/day versus placebo for 22 weeks among persons 20-40 years of age.

Primary Outcomes

Measure
Blood pressure
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
HbA1c
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)

Secondary Outcomes

Measure
High-density lipoproteins (HDL) cholesterol
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
Low-density lipoproteins (LDL) cholesterol
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
Total cholesterol
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
Triglycerides
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
Parathyroid hormone (PTH)
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
Fasting glucose
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
Fasting insulin
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
C-peptide
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)
Two-hour glucose
time frame: Participants were followed for the duration of the intervention period (range 8 weeks - 1 year, depending on the RCT in which they are participating)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Availability of quality bio-banked samples for uniform 25(OH)D re-measurement - Prospective data on one or more of the outcomes - Willingness to collaborate Exclusion Criteria: - Trials among pregnant women, children, or performed in patient populations.

Additional Information

Official title The Effect of Vitamin D Supplementation on Markers for Cardiovascular Disease and Diabetes: an Individual Participant Data Meta-analysis of Randomized Controlled Trials
Description Large randomized controlled trials (RCTs) are currently on-going to evaluate non-skeletal effects of vitamin D supplementation in the general older population. The results of these studies can be expected in 2017 to 2020 and while they will report important data, they may still leave knowledge gaps on the effects of vitamin D on clinically relevant surrogate parameters in specific groups. Recent data indicate that the association of vitamin D status and outcome is U- or reverse J-shaped and may be modified by the presence of certain risk factors or genetic variations of the vitamin D receptor. This work is part of the European Union-project 'Food-based solutions for eradication of vitamin D deficiency and health promotion throughout the life cycle' (ODIN). This individual patient meta-analysis of existing high quality vitamin D RCTs aims to evaluate whether there are beneficial or harmful vitamin D effects on surrogate parameters for clinical outcomes (i.e. blood pressure, lipids, parathyroid hormone (PTH), fasting blood glucose and glycated haemoglobin (HbA1c)). With data from almost 3000 randomized subjects from 12 RCTs that are available within this consortium, the investigators will have sufficient power to detect clinically relevant effects of vitamin D supplementation on risk factors for cardiovascular disease. Subgroup analyses will investigate effect modifiers to evaluate whether certain groups of individuals experience pronounced or attenuated effects from vitamin D supplementation. Given that previous data suggest that vitamin D supplementation might be most effective in those individuals with very low 25(OH)D and potentially harmful in those achieving very high levels after vitamin D supplementation, this individual patient data meta-analyses will be performed in subgroups with serum 25(OH)D levels <30, 40, and 50 nmol/L and >100, 125 and 150 nmol/L. 25(OH)D levels will be re-measured to ensure comparability.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by VU University Medical Center.