Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals
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|ClinicalTrials.gov Identifier: NCT01170468|
Recruitment Status : Terminated (inadequate enrollement)
First Posted : July 27, 2010
Last Update Posted : March 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Vitamin D3 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||January 15, 2014|
|Actual Study Completion Date :||January 15, 2014|
Experimental: Vitamin D3
Vitamin D3 5000 IU daily
Drug: Vitamin D3
Vitamin D3 5000 IU orally, daily for 2 years
Other Name: cholecalciferol
Placebo Comparator: Placebo
Placebo orally, daily for 2 years
- The incidence of DM [ Time Frame: 2 years ]Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
- slope of fasting glucose level [ Time Frame: 2 years ]
- slope of 2-hour post challenge glucose level [ Time Frame: 2 years ]
- area under the curve of BP [ Time Frame: 2 years ]
- area under the curve of weight [ Time Frame: 2 years ]
- area under the curve of 25 OH vitamin D level [ Time Frame: 2 years ]
- fasting insulin to glucose ratio [ Time Frame: 2 years ]
- incidence of hypercalcemia [ Time Frame: 2 years ]
- incidence of hypercalciuria [ Time Frame: 2 years ]
- time to develop DM [ Time Frame: 2 years ]Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170468
|King Faisal Specialist Hospital & Research Center|
|Riyadh, Saudi Arabia, 11211|
|Principal Investigator:||Muhammad M Hammami, MD, PhD||King Faisal Specialist Hospital & Research Center|