Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals

Phase 3

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Vitamin D3

• Registration Number: NCT01170468
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-25
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Study Start: 2011-12
• Primary Completion: 2014-01-15
• Study Completion: 2014-01-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo daily
Vitamin D3	Vitamin D3	Vitamin D3 5000 IU daily

Primary Outcome Measures

Name	Time	Method
The incidence of DM	2 years	Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.

Secondary Outcome Measures

Name	Time	Method
area under the curve of 25 OH vitamin D level	2 years
fasting insulin to glucose ratio	2 years
slope of fasting glucose level	2 years
slope of 2-hour post challenge glucose level	2 years
area under the curve of BP	2 years
area under the curve of weight	2 years
incidence of hypercalcemia	2 years
incidence of hypercalciuria	2 years
time to develop DM	2 years	Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.

Trial Locations

Locations (1)

King Faisal Specialist Hospital & Research Center; 🇸🇦 Riyadh, Saudi Arabia