Vitamin D Deficiency Clinical Trial
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
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.
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.
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Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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|
Phase 1/Phase 2 | |
| Recruiting |
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|
N/A | |
| Completed |
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|
Phase 3 | |
| Suspended |
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Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
| Completed |
NCT03920150 -
Vitamin D 24'000 IU for Oral Intermittent Supplementation
|
Phase 3 | |
| Completed |
NCT03264625 -
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
|
Phase 2 | |
| Completed |
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Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
| Recruiting |
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Vitamin D Deficiency in Adults Following a Major Burn Injury
|
Phase 4 | |
| Completed |
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|
N/A | |
| Completed |
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|
Phase 3 | |
| Completed |
NCT03234218 -
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|
||
| Completed |
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|
N/A | |
| Completed |
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Corneal Nerve Structure in Sjogren's
|
||
| Completed |
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A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
N/A | |
| Completed |
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Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
|
N/A | |
| Completed |
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|
N/A | |
| Not yet recruiting |
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|
N/A | |
| Completed |
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The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
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N/A | |
| Completed |
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|
Phase 4 | |
| Completed |
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|
N/A |