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Randomized, Controlled Trial of Vitamin D Replenishment in Metabolic Syndrome

ClinicalTrials.gov · COMPLETED, 2014

84 participants

Abstract

Vitamin D deficiency is widespread and appears to represent one easily and inexpensively modifiable risk factor for diabetes and cardiovascular disease. More than 40 years of data link hypovitaminosis D to metabolic syndrome, insulin resistance, hyperglycemia, type 2 diabetes and increased cardiovascular risk.

Screening for vitamin D deficiency followed by supplementation in appropriate individuals could be among the simplest and most cost-effective measures for reducing metabolic syndrome and insulin resistance in the general population.

This study will test the hypothesis that increasing vitamin D status in vitamin D deficient individuals with metabolic syndrome will:

1. reduce multiple serum cardiometabolic risk factors for both diabetes and cardiovascular disease,

2. stabilize or reverse the stage of pre-diabetes,

3. improve quality of life, and,

4. improve the ability to make health-related behavioral changes.

Conditions: Metabolic Syndrome.

Primary outcome: insulin resistance score by NMR lipid fractionation; Reynolds Risk Score; Pre-diabetes stage.

Enrollment: 84 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 84 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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