Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial.

What Was Tested

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

Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial.

The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglitazone and pioglitazone) on cardiovascular outcomes and the effects of vitamin D (cholecalciferol) on cancers and mortality.

Who Took Part

According to the abstract, 1,332 people were involved.

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

A large multicentre 3 × 2 factorial double-blind placebo-controlled randomised trial recruited from outpatient primary care and specialty clinics in 33 countries.

Participants and all study personnel were blind to treatment allocation.

How the Study Was Run

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

The people were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

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

Some people received a placebo instead of Vitamin D, K2, Magnesium and Zinc, giving a reference point.

Running at several centres spread the Vitamin D, K2, Magnesium and Zinc study over different clinics and patient groups.

All randomised participants were included in the primary analysis.

What Was Measured

Topics PubMed links to this paper include Cardiovascular Diseases, Cholecalciferol, Combined Modality Therapy, Diabetes Mellitus, Type 2, Dietary Supplements, Early Termination of Clinical Trials and Hypoglycemic Agents.

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 1,332 people.

With several hundred people or more, it is a fairly large study for this kind of research.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2012 (Diabetologia), a journal based in Germany.

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