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Trial record 63 of 123 for:    hypertension "vitamin d"

Vitamin D Supplements on Markers for Cardiovascular Disease and Diabetes: an Individual Participant Data Meta-analysis

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ClinicalTrials.gov Identifier: NCT02551835
Recruitment Status : Unknown
Verified March 2016 by Karin Swart, VU University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2015
Last Update Posted : March 2, 2016
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Karin Swart, VU University Medical Center

Brief 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.

Condition or disease
Vitamin D Deficiency Vitamin; Excess Vitamin D (Nutritional)

Detailed 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.


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Study Type : Observational
Actual Enrollment : 2945 participants
Time Perspective: Prospective
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
Study Start Date : April 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort
Tromso Impaired Glucose Tolerance (IGT) study
RCT on 20000 IU vitamin D3/week versus placebo for 1 year among persons with impaired glucose tolerance and/or impaired fasting glucose.
Tromso OBESITY study
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.
Tromso Bone Mineral Density (BMD) study
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.
Tromso CLAMP study
RCT on 40000 IU vitamin D3/week versus placebo for 6 months among persons with 25(OH)D values <42 nmol/L.
Tromso DEPRESSION study
RCT on 40000 IU vitamin D3/week versus placebo for 6 months among persons with 25(OH)D values <55 nmol/L.
Styrian Vitamin D Hypertension Trial
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.
Paravit study
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.
Oosterwerff study
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.
Chel study
RCT on 600 IU vitamin D3/day (or daily equivalent) versus placebo for 4 months among nursing home residents >70 years of age.
Wicherts study
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.
University College Cork (UCC) 1 study
RCT on 200, 400, or 600 IU vitamin D3/day versus placebo for 22 weeks among persons > 63 years of age.
UCC 2 study
RCT on 200, 400, or 600 IU vitamin D3/day versus placebo for 22 weeks among persons 20-40 years of age.



Primary Outcome Measures :
  1. 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) ]
    Systolic and diastolic (Main outcome of cardiovascular markers)

  2. 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) ]
    (Main outcome of diabetic markers)


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
    Parathyroid hormone

  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
    After oral glucose tolerance test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The participating RCTs are the Tromso IGT, Tromso OBESITY, Tromso BMD, Tromso CLAMP, Tromso DEPRESSION, Styrian Vitamin D Hypertension Trial, Paravit, Oosterwerff, Chel, Wicherts, UCC1, and UCC2 trials.
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karin Swart, PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02551835     History of Changes
Other Study ID Numbers: ODIN 8.3
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016

Keywords provided by Karin Swart, VU University Medical Center:
ODIN
Meta-analysis
Cholecalciferol
25(OH)D
Subgroup effects

Additional relevant MeSH terms:
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Vitamin D Deficiency
Vitamin D
Cardiovascular Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents