Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?

Study Overview
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Brief Summary
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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

Official Title
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Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial

Conditions
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Vitamin D Deficiency, 25-Hydroxyvitamin D Concentration

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Vitamin D2
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: non-pregnant adults (age ≥18 years) healthy total 25(OH)D level between 20 to 65 nmol/L. living in Riyadh area Exclusion criteria: consumption of more than one serving of milk daily taking vitamin D supplements habitual weekly sun exposure of 10 hours or more history of granulomatous, liver, or kidney disease taking anticonvulsants, barbiturates, or steroids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group-2-D3<br>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 | Drug: Vitamin D3<br>* Single oral dose of 50,000 IU of vitamin D3<br>* Other names: cholecalciferol;Drug: Vitamin D2<br>* Single oral dose of 50,000 IU of vitamin D2<br>* Other names: Ergocalciferol;|
| Placebo Comparator: Group-2-Placebo<br>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. | Drug: Vitamin D2<br>* Single oral dose of 50,000 IU of vitamin D2<br>* Other names: Ergocalciferol;Drug: Placebo oral capsule<br>* Placebo oral capsule<br>|
| Experimental: Group-1-D2<br>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. | Drug: Vitamin D2<br>* Single oral dose of 50,000 IU of vitamin D2<br>* Other names: Ergocalciferol;|
| Placebo Comparator: Group-1-Placebo<br>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. | Drug: Placebo oral capsule<br>* Placebo oral capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |