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inadequate enrollement
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | Vitamin D3 5000 IU daily |
|
| Placebo | Placebo Comparator | Placebo daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Vitamin D3 5000 IU orally, daily for 2 years |
|
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad M Hammami, MD, PhD | King Faisal Specialist Hospital & Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital & Research Center | Riyadh | 11211 | Saudi Arabia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Placebo orally, daily for 2 years |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |