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Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.
The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D2 2000 IU daily | Active Comparator |
| |
| D3 2000 IU daily | Active Comparator |
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| D2 1000 IU + D3 1000 IU daily | Active Comparator |
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| D2 25000 IU Q2wk | Active Comparator |
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| D3 25000 IU Q2wk | Active Comparator |
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| D2 50000 IU Q4wk | Active Comparator |
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| D3 50000 IU Q4wk | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ergocalciferol 2000 IU orally, daily | Drug | ergocalciferol 2000 IU orally, daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve of 25 OH vitamin D level | area under the curve of total 25 OH vitamin D level from day 1 to 140 | 140 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of 25 OH vitamin D | Cmax of total 25 OH vitamin D over the treatment period of 140 days | 140 days |
| Tmax of 25 OH vitamin D level | Tmax of total 25 OH vitamin D over the treatment period of 140 days |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28231782 | Derived | Hammami MM, Yusuf A. Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. BMC Endocr Disord. 2017 Feb 24;17(1):12. doi: 10.1186/s12902-017-0163-9. |
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| placebo daily | Placebo Comparator |
|
| ergocalciferol 25000 IU oraly every 2 weeks | Drug | ergocalciferol 25000 IU oraly every 2 weeks |
|
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| ergocalciferol 50000 IU orally every 4 weeks | Drug | ergocalciferol 50000 IU orally every 4 weeks |
|
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| ergocal1000 IU & cholecal 1000 IU orally daily | Drug | ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day |
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| cholecalciferol 2000 IU orally daily | Drug | cholecalciferol 2000 IU orally everyday |
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| Cholecalciferol 25000 IU orally every 2 weeks | Drug | Cholecalciferol 25000 IU orally every 2 weeks |
|
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| Cholecalciferol 50000 orally every 4 weeks | Drug | Cholecalciferol 50000 orally every 4 weeks |
|
|
| placebo orally everyday | Drug | placebo orally everyday |
|
|
| 140 days |
| area under the curve of vitamin D level | area under the curve of total vitamin D level over 140 days | 140 days |
| incidence of hypercalcemia | 140 days |
| incidence of hypercalciuria | 140 days |
| 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 |
|---|---|
| D004872 | Ergocalciferols |
| 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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