Does Vitamin D Improve Glycemic Control in Type II DM?

Does Vitamin D Improve Glycemic Control in Type II DM? A Double Blind Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus; Vitamin D Deficiency
• Intervention / Treatment: Drug: vitamin D3 2000 IU; Drug: vitamin D3 5000 IU; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; placebo orally, daily for six months
Experimental: vitamin D3 2000 IU	Drug: vitamin D3 2000 IU; vitamin D3 2000 IU orally, daily for 6 months; Other Names: cholecalciferol
Experimental: vitamin D3 5000 IU	Drug: vitamin D3 5000 IU; vitamin D3 5000 IU orally, daily for 6 months; Other Names: cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve of HA1C.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 25, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: RAC 2101039