Effect of Vitamin D Replacement on Insulin Sensitivity

Summary

Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.

Timeline

Start

2011-01

Primary completion

2012-03

Completion

2012-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Vitamin D vs Placebo; p = 0.4; t-test, 2 sided NCT01268111 ↗

paper Glucose infusion rate was similar between the 2 groups both at baseline and after 8 weeks of treatment. PMID 23111651 ↗

Publications

• Results Simha V, Mahmood M, Ansari M, Spellman CW, Shah P. Effect of vitamin D replacement on insulin sensitivity in subjects with vitamin D deficiency. J Investig Med. 2012 Dec;60(8):1214-8. doi: 10.2310/JIM.0b013e3182747c06.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ergocalciferol	Small molecule	50000 iu	Oral

Indications

No indication recorded.