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Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.
The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D3 1000 IU | Active Comparator |
| |
| Vitamin D3 3000 IU | Active Comparator |
| |
| Vitamin D3 5000 IU | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 1000 IU orally daily for 5 months | Drug |
| ||
| vitamin D3 3000 IU orally daily for 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of 25 OH vitamin D3 level vs vitamin D3 dose | The primary endpoint is the slope of the dose (vitamin D3)- response (25 OH vitamin D3 level) curve for each cohort. The slope of the placebo group will be used to determine changes in 25 OH vitamin D3 levels that are not related to study intervention. The slope will be determined over 5 months. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| slope of vitamin D3 level vs vitamin D3 dose | slope of vitamin D3 level vs vitamin D3 dose over 5 months | 5 months |
| incidence of hypercalcemia | incidence of hypercalcemia over 8 months |
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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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| Drug |
|
| vitamin D3 5000 IU orally daily for 5 months | Drug |
|
| Placebo orally daily for 5 months | Drug |
|
| 8 months |
| incidence of hypercalciuria | incidence of hypercalciuria over 8 months | 8 months |
| slope of decline of 25 OH vitamin D3 level vs time | slope of decline of 25 OH vitamin D3 level vs time over 3 months | 3 months |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| 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 |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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