Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: ergocalciferol 2000 IU orally, daily
* Drug: ergocalciferol 25000 IU oraly every 2 weeks
* Drug: ergocalciferol 50000 IU orally every 4 weeks
* Drug: ergocal1000 IU & cholecal 1000 IU orally daily
* Drug: cholecalciferol 2000 IU orally daily
* Drug: Cholecalciferol 25000 IU orally every 2 weeks
* Drug: Cholecalciferol 50000 orally every 4 weeks
* Drug: placebo orally everyday


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids. 25 OH vitamin D level between 20 to 50 nmol/L.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D2 2000 IU daily<br> | Drug: ergocalciferol 2000 IU orally, daily<br>* ergocalciferol 2000 IU orally, daily<br>* Other names: ergocalciferol;|
| Active Comparator: D3 2000 IU daily<br> | Drug: cholecalciferol 2000 IU orally daily<br>* cholecalciferol 2000 IU orally everyday<br>* Other names: cholecalciferol;|
| Active Comparator: D2 1000 IU + D3 1000 IU daily<br> | Drug: ergocal1000 IU & cholecal 1000 IU orally daily<br>* ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day<br>* Other names: ergocalciferol and cholecalciferol;|
| Active Comparator: D2 25000 IU Q2wk<br> | Drug: ergocalciferol 25000 IU oraly every 2 weeks<br>* ergocalciferol 25000 IU oraly every 2 weeks<br>* Other names: ergocalciferol;|
| Active Comparator: D3 25000 IU Q2wk<br> | Drug: Cholecalciferol 25000 IU orally every 2 weeks<br>* Cholecalciferol 25000 IU orally every 2 weeks<br>* Other names: Cholecalciferol;|
| Active Comparator: D2 50000 IU Q4wk<br> | Drug: ergocalciferol 50000 IU orally every 4 weeks<br>* ergocalciferol 50000 IU orally every 4 weeks<br>* Other names: ergocalciferol;|
| Active Comparator: D3 50000 IU Q4wk<br> | Drug: Cholecalciferol 50000 orally every 4 weeks<br>* Cholecalciferol 50000 orally every 4 weeks<br>* Other names: Cholecalciferol;|
| Placebo Comparator: placebo daily<br> | Drug: placebo orally everyday<br>* placebo orally everyday<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3