Rationale and design of Diabetes Prevention with active Vitamin D (DPVD): a randomised, double-blind, placebo-controlled study.

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc, published as a randomized controlled trial.

However, most of these data come from observational studies, and clinical trial data on the effects of vitamin D supplementation on individuals with pre-diabetes are scarce and inconsistent.

All protocols and an informed consent form comply with the Ethics Guideline for Clinical Research (Japan Ministry of Health, Labour and Welfare).

Who Took Part

The study group was 2 individuals.

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

Participants, men and women aged ≥30 years, will be randomised to receive eldecalcitol or placebo.

Secondary endpoint is the number of participants who achieve normoglycaemia at 48, 96 and 144 weeks.

How the Study Was Run

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

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

Blinding on both sides kept the individuals and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

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

More than one site took part, so the individuals came from several places.

DPVD is an ongoing, prospective, multicentre, randomised, double-blind and placebo-controlled outcome study in individuals with impaired glucose tolerance.

They will also be given a brief (5-10 min long) talk about appropriate calorie intake from diet and exercise at each 12-week visit.

The primary end point is the cumulative incidence of type 2 diabetes.

Follow-up is estimated to span 144 weeks.

What Was Measured

Topics PubMed links to this paper include Bone Density Conservation Agents, Diabetes Mellitus, Type 2, Diet, Dietary Supplements, Exercise, Glucose Intolerance and Japan.

Author keywords: DIABETES & ENDOCRINOLOGY.

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 2 individuals.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2016 (BMJ open), a journal based in England.

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