Study protocol: the effect of vitamin D supplements on cardiometabolic risk factors among urban premenopausal women in a tropical country -- a randomized controlled trial.

What Was Tested

This randomized controlled trial looks at Vitamin D, K2, Magnesium and Zinc.

However, few published studies that measured its effect on cardiometabolic risk factors were found in Malaysia.

There are also limited clinical trials carried out globally that tried to establish the causality of vitamin D and cardiometabolic risks.

Who Took Part

The age groups tagged for this paper are adults, women only.

Both participants and researchers will be blinded.

The serum vitamin D levels of all participants collected at various time points will only be analysed at the end of the trial.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and parallel-group.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

A placebo (an inactive look-alike) gave the Vitamin D, K2, Magnesium and Zinc group a baseline to be compared against.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

Outcome measures such as 25(OH) D3, HOMA-IR, blood pressure, full lipid profiles will be taken at baseline, 6 months and 12 months.

Health related quality of life will be measured at baseline and 12 months.

What Was Measured

However, few published studies that measured its effect on cardiometabolic risk factors were found in Malaysia.

The subject headings attached to it are Cardiovascular Diseases, Dietary Supplements, Exercise, Health Status Indicators, Malaysia, Metabolic Diseases and Premenopause.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc.

The abstract goes on to report its results in about 2 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2013 (BMC public health), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.