Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments vitamin d3, placebo
Phase phase 3
Sponsor King Faisal Specialist Hospital & Research Center
Start date December 2011
End date December 2016
Trial size 500 participants
Trial identifier NCT01170468, RAC 2101040

Summary

Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established.

The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Vitamin D3 5000 IU daily
vitamin d3 cholecalciferol
Vitamin D3 5000 IU orally, daily for 2 years
(Placebo Comparator)
Placebo daily
placebo
Placebo orally, daily for 2 years

Primary Outcomes

Measure
The incidence of DM
time frame: 2 years

Secondary Outcomes

Measure
slope of fasting glucose level
time frame: 2 years
slope of 2-hour post challenge glucose level
time frame: 2 years
area under the curve of BP
time frame: 2 years
area under the curve of weight
time frame: 2 years
area under the curve of 25 OH vitamin D level
time frame: 2 years
fasting insulin to glucose ratio
time frame: 2 years
incidence of hypercalcemia
time frame: 2 years
incidence of hypercalciuria
time frame: 2 years
time to develop DM
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l - Who consume no more than one serving of milk/day - Do not take vitamin supplement - Habitually have less than 10 hour of sun exposure per week - Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes - Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.

Additional Information

Official title Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial
Principal investigator Muhammad M Hammami, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by King Faisal Specialist Hospital & Research Center.