Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals

Study Overview
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Brief Summary
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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.

Official Title
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Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l 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 granulomatus conditions, liver disease, kidney disease, or diabetes Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>Vitamin D3 5000 IU daily | Drug: Vitamin D3<br>* Vitamin D3 5000 IU orally, daily for 2 years<br>* Other names: cholecalciferol;|
| Placebo Comparator: Placebo<br>Placebo daily | Drug: Placebo<br>* Placebo orally, daily for 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of DM | Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| slope of fasting glucose level |  | 2 years | 
| slope of 2-hour post challenge glucose level |  | 2 years | 
| area under the curve of BP |  | 2 years | 
| area under the curve of weight |  | 2 years | 
| area under the curve of 25 OH vitamin D level |  | 2 years | 
| fasting insulin to glucose ratio |  | 2 years | 
| incidence of hypercalcemia |  | 2 years | 
| incidence of hypercalciuria |  | 2 years | 
| time to develop DM | Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetics, DM, vitamin D