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Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level.
The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-2-D3 | Experimental | Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3 |
|
| Group-2-Placebo | Placebo Comparator | Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule. |
|
| Group-1-D2 | Experimental | Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2. |
|
| Group-1-Placebo | Placebo Comparator | Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Single oral dose of 50,000 IU of vitamin D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 | day 28 | |
| ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1 | day 56 | |
| ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2 | day 56 | |
| Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad M Hammami, MD, PhD | King Faisal Specialist Hospital & Research Center (Riydah) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital & Research Center | Riyadh | Central | 11211 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30658603 | Derived | Hammami MM, Abuhdeeb K, Hammami S, Yusuf A. Vitamin-D2 treatment-associated decrease in 25(OH)D3 level is a reciprocal phenomenon: a randomized controlled trial. BMC Endocr Disord. 2019 Jan 18;19(1):8. doi: 10.1186/s12902-019-0337-8. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D004872 | Ergocalciferols |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Vitamin D2 | Drug | Single oral dose of 50,000 IU of vitamin D2 |
|
|
| Placebo oral capsule | Drug | Placebo oral capsule |
|
| day 28 |
| Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level | day 28 |
| Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group | day 28 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |