Does Vitamin D Improve Glycemic Control in Type II DM?

Phase 3

Terminated

• Conditions: Diabetes Mellitus; Vitamin D Deficiency
• Interventions: Drug: vitamin D3 2000 IU; Drug: vitamin D3 5000 IU; Drug: Placebo

• Registration Number: NCT01170442
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief Summary

Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.

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: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

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

Inclusion Criteria

• Type II diabetics living in Riyadh area 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 granulomatous conditions, liver disease, or kidney disease
• Don't take anticonvulsants, barbiturates, or steroids.
• Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier)
• Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D3 2000 IU	vitamin D3 2000 IU	-
vitamin D3 5000 IU	vitamin D3 5000 IU	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Area under the curve of HA1C.	6 months

Secondary Outcome Measures

Name	Time	Method
incidence of hypercalciuria	6 months
area under the curve of fasting blood glucose	6 months
fasting insulin to glucose ratio	6 months
area under the curve of weight	6 months
incidence of hypercalcemia	6 months
Area under the curve for BP	6 months
area under the curve of 2 hour post breakfast glucose	6 months
area under the curve for 25 OH vitamin D level	6 months

Trial Locations

Locations (1)

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