DIVINE
A Randomized Controlled Trial of the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Subjects With Type 2 Diabetes of Nordic and Sub-Indian Ethnicity .
Sponsor study identifier
interventional
60
1 country
1
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 5, 2009
Actual (reported)October 9, 2009
Actual (reported)December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp
Before and after the 6 months intervention period
Insulin secretion measured with IVGTT
At 0 and 6 months
Physical activity/muscle strength
At 0 and 6 months
HbA1c and fasting glucose
At 0, 3 and 6 months
Arterial stiffness
At 0 and 6 months
Differences in inflammatory markers, endothelial function and bone specific laboratory markers.
At 0, 3 and 6 months
Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D \< 100 nmol/L. If serum 25(OH)D \> 100 placebo will be given. The cholecalciferol will be given in orange juice.
Orange juice at randomization day and at week 5.
Diabetes Laboratory, Oslo University Hospital Aker
Oslo, 0514, Norway
Gulseth HL, Wium C, Angel K, Eriksen EF, Birkeland KI. Effects of Vitamin D Supplementation on Insulin Sensitivity and Insulin Secretion in Subjects With Type 2 Diabetes and Vitamin D Deficiency: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):872-878. doi: 10.2337/dc16-2302. Epub 2017 May 3.
Kåre I Birkeland, MD PhD
Oslo University Hospital
First Submitted
October 5, 2009
First Posted
October 9, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Estimated (date passed)Vitamin D, Blood Pressure, Lipids, Infection and Depression
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 3, 2009
Record last verified: 2009-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: