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Does Vitamin D Improve Glycemic Control in Type II DM?

Primary Purpose

Diabetes Mellitus, Vitamin D Deficiency

Status
Terminated
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
vitamin D3 2000 IU
vitamin D3 5000 IU
Placebo
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Faisal Specialist Hospital & Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

vitamin D3 2000 IU

vitamin D3 5000 IU

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Area under the curve of HA1C.

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2010
Last Updated
March 31, 2015
Sponsor
King Faisal Specialist Hospital & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01170442
Brief Title
Does Vitamin D Improve Glycemic Control in Type II DM?
Official Title
Does Vitamin D Improve Glycemic Control in Type II DM? A Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
In adequate enrollment
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Faisal Specialist Hospital & Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D3 2000 IU
Arm Type
Experimental
Arm Title
vitamin D3 5000 IU
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
vitamin D3 2000 IU
Other Intervention Name(s)
cholecalciferol
Intervention Description
vitamin D3 2000 IU orally, daily for 6 months
Intervention Type
Drug
Intervention Name(s)
vitamin D3 5000 IU
Other Intervention Name(s)
cholecalciferol
Intervention Description
vitamin D3 5000 IU orally, daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo orally, daily for six months
Primary Outcome Measure Information:
Title
Area under the curve of HA1C.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Area under the curve for BP
Time Frame
6 months
Title
area under the curve of weight
Time Frame
6 months
Title
area under the curve for 25 OH vitamin D level
Time Frame
6 months
Title
area under the curve of fasting blood glucose
Time Frame
6 months
Title
area under the curve of 2 hour post breakfast glucose
Time Frame
6 months
Title
fasting insulin to glucose ratio
Time Frame
6 months
Title
incidence of hypercalcemia
Time Frame
6 months
Title
incidence of hypercalciuria
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad M Hammami, MD, PhD
Organizational Affiliation
King Faisal Specialist Hospital & Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia

12. IPD Sharing Statement

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Does Vitamin D Improve Glycemic Control in Type II DM?

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