Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
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ClinicalTrials.gov Identifier: NCT01170494 |
Recruitment Status :
Completed
First Posted : July 27, 2010
Last Update Posted : August 31, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vitamin D Deficiency | 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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 279 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: D2 2000 IU daily |
Drug: ergocalciferol 2000 IU orally, daily
ergocalciferol 2000 IU orally, daily
Other Name: ergocalciferol |
Active Comparator: D3 2000 IU daily |
Drug: cholecalciferol 2000 IU orally daily
cholecalciferol 2000 IU orally everyday
Other Name: cholecalciferol |
Active Comparator: D2 1000 IU + D3 1000 IU daily |
Drug: ergocal1000 IU & cholecal 1000 IU orally daily
ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day
Other Name: ergocalciferol and cholecalciferol |
Active Comparator: D2 25000 IU Q2wk |
Drug: ergocalciferol 25000 IU oraly every 2 weeks
ergocalciferol 25000 IU oraly every 2 weeks
Other Name: ergocalciferol |
Active Comparator: D3 25000 IU Q2wk |
Drug: Cholecalciferol 25000 IU orally every 2 weeks
Cholecalciferol 25000 IU orally every 2 weeks
Other Name: Cholecalciferol |
Active Comparator: D2 50000 IU Q4wk |
Drug: ergocalciferol 50000 IU orally every 4 weeks
ergocalciferol 50000 IU orally every 4 weeks
Other Name: ergocalciferol |
Active Comparator: D3 50000 IU Q4wk |
Drug: Cholecalciferol 50000 orally every 4 weeks
Cholecalciferol 50000 orally every 4 weeks
Other Name: Cholecalciferol |
Placebo Comparator: placebo daily |
Drug: placebo orally everyday
placebo orally everyday
Other Name: placebo |
- area under the curve of 25 OH vitamin D level [ Time Frame: 140 days ]area under the curve of total 25 OH vitamin D level from day 1 to 140
- Cmax of 25 OH vitamin D [ Time Frame: 140 days ]Cmax of total 25 OH vitamin D over the treatment period of 140 days
- Tmax of 25 OH vitamin D level [ Time Frame: 140 days ]Tmax of total 25 OH vitamin D over the treatment period of 140 days
- area under the curve of vitamin D level [ Time Frame: 140 days ]area under the curve of total vitamin D level over 140 days
- incidence of hypercalcemia [ Time Frame: 140 days ]
- incidence of hypercalciuria [ Time Frame: 140 days ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170494
Saudi Arabia | |
King Faisal Specialist Hospital & research Center | |
Riyadh, Saudi Arabia, 11211 |
Principal Investigator: | Muhammad M Hammami, MD, PhD | King Faisal Specialist Hospital & Research Center |
Responsible Party: | Muhammad Maher Hammami, Chairman, Department of Clinical Studies & Empirical Ethics, King Faisal Specialist Hospital & Research Center |
ClinicalTrials.gov Identifier: | NCT01170494 |
Other Study ID Numbers: |
RAC 2101041 |
First Posted: | July 27, 2010 Key Record Dates |
Last Update Posted: | August 31, 2016 |
Last Verified: | August 2016 |
vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3 |
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Cholecalciferol Ergocalciferols Vitamin D |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents |