Study protocol: a randomised placebo-controlled clinical trial to s tu dy the effect of vitamin D supplemen tation on gly ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-12

AUTHORS

Yvonne HM Krul-Poel, Hans van Wijland, Frank Stam, Edwin ten Boekel, Paul Lips, Suat Simsek

ABSTRACT

BACKGROUND: 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. 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. METHODS/DESIGN: In a randomised double-blind placebo-controlled trial conducted in five general practices in the Netherlands three hundred patients with type 2 diabetes mellitus treated with lifestyle advises or metformin or sulphonylurea-derivatives are randomised to receive either placebo or 50,000 IU Vitamin D3 at monthly intervals. 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. DISCUSSION: This trial will be the first study exploring the effect of vitamin D supplementation on both glycaemic control and quality of life in patients with type 2 diabetes mellitus. Our findings will contribute to the knowledge of the relationship between vitamin D status and insulin resistance in patients with type 2 diabetes mellitus. TRIAL REGISTRATION: The Netherlands trial register: NTR3154. More... »

PAGES

59

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1472-6823-14-59

DOI

http://dx.doi.org/10.1186/1472-6823-14-59

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1050624232

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/25033925


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curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/1472-6823-14-59'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/1472-6823-14-59'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/1472-6823-14-59'


 

This table displays all metadata directly associated to this object as RDF triples.

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