Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial.

What Was Tested

Researchers studied Vitamin D, K2, Magnesium and Zinc in this randomized controlled trial publication.

The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes.

Why It Was Studied

Sri Lanka Clinical Trial Registry: SLCTR/2012/010.

Who Took Part

The study group was 200 adults.

PubMed indexes the participants as teenagers, young adults, adults and middle-aged adults, both men and women.

A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study.

The study drugs will be double blinded to both investigators and subjects.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

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

The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189).

They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio.

The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4).

The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale.

Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire.

What Was Measured

The subject headings attached to it are Appetite, Biomarkers, Blood Glucose, Capsules, Clinical Protocols, Dietary Supplements and Disease Progression.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 200 adults.

Its findings take up roughly 1 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2013 (Trials), a journal based in England.

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