Study protocol: a randomised placebo-controlled clinical trial to study the effect of vitamin D supplementation on glycaemic control in type 2 Diabetes Mellitus SUNNY trial.

What Was Tested

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

There are limited clinical trials carried out which measured the effect of vitamin D supplementation on glycaemic control.The objective of this study is to investigate the effect of vitamin D supplementation on glycaemic control and quality of life in patients with type 2 diabetes mellitus.

Why It Was Studied

Besides the classical role of vitamin D on calcium and bone homeostasis, vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus.

However, it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus.

Who Took Part

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

How the Study Was Run

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

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

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

The comparison arm used a placebo, so changes seen with Vitamin D, K2, Magnesium and Zinc could be set against what happens without it.

The primary outcome measure is the change in glycated haemoglobin level between baseline and six months.

Secondary outcome measures include blood pressure, anthropometric parameters, lipid profile, insulin resistance, quality of life, advanced glycation end products and safety profiles.

Quality of life will be measured by The Short Form (SF-36) Health Survey questionnaire.

Advanced glycation end products are measured by an AGE-reader.

What Was Measured

The subject headings attached to it are Biomarkers, Blood Glucose, Clinical Protocols, Diabetes Mellitus, Type 2, Dietary Supplements, Glycated Hemoglobin and Hyperglycemia.

What This Means in Plain Language

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

Results are reported in around 2 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2014 (BMC endocrine disorders), a journal based in England.

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