Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2013 by King Faisal Specialist Hospital & Research Center
Sponsor:
King Faisal Specialist Hospital & Research Center
Information provided by (Responsible Party):
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01170494
First received: July 25, 2010
Last updated: December 10, 2013
Last verified: December 2013
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by King Faisal Specialist Hospital & Research Center:
Primary Outcome Measures:
- area under the curve of 25 OH vitamin D level [ Time Frame: 140 days ] [ Designated as safety issue: No ]area under the curve of total 25 OH vitamin D level from day 1 to 140
Secondary Outcome Measures:
- Cmax of 25 OH vitamin D [ Time Frame: 140 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]area under the curve of total vitamin D level over 140 days
- incidence of hypercalcemia [ Time Frame: 140 days ] [ Designated as safety issue: Yes ]
- incidence of hypercalciuria [ Time Frame: 140 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 800 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170494
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170494
Contacts
| Contact: Muhammad M Hammami, MD, PhD | 966 1 442 4527 | muhammad@kfshrc.edu.sa |
Locations
| Saudi Arabia | |
| King Faisal Specialist Hospital & research Center | Recruiting |
| Riyadh, Saudi Arabia, 11211 | |
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
| Principal Investigator: | Muhammad M Hammami, MD, PhD | King Faisal Specialist Hospital & Research Center |
More Information
No publications provided
| Responsible Party: | Muhammad Maher Hammami, Chairman, Department of Clinical Studies & Empirical Ethics, King Faisal Specialist Hospital & Research Center |
| ClinicalTrials.gov Identifier: | NCT01170494 History of Changes |
| Other Study ID Numbers: | RAC 2101041 |
| Study First Received: | July 25, 2010 |
| Last Updated: | December 10, 2013 |
| Health Authority: | Saudi Arabia:National Committee of Biological and Medical Ethics |
Keywords provided by King Faisal Specialist Hospital & Research Center:
|
vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3 |
Additional relevant MeSH terms:
|
Ergocalciferols Vitamin D Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
Cholecalciferol Vitamins Bone Density Conservation Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 01, 2015