Study Stopped
In adequate enrollment
Does Vitamin D Improve Glycemic Control in Type II DM?
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2010
CompletedFirst Posted
Study publicly available on registry
July 27, 2010
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 1, 2015
March 1, 2015
2 years
July 25, 2010
March 31, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the curve of HA1C.
6 months
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (3)
vitamin D3 2000 IU
EXPERIMENTALvitamin D3 5000 IU
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
vitamin D3 2000 IU orally, daily for 6 months
vitamin D3 5000 IU orally, daily for 6 months
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Faisal Specialist Hospital & Research Center
Riyadh, 11211, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad M Hammami, MD, PhD
King Faisal Specialist Hospital & Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman, Department of Clinical Studies & Empirical Ethics
Study Record Dates
First Submitted
July 25, 2010
First Posted
July 27, 2010
Study Start
December 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 1, 2015
Record last verified: 2015-03