Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation
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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. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.
The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.
| Condition | Intervention | Phase |
|---|---|---|
| Vitamin D Deficiency | Drug: vitamin D3 1000 IU orally daily for 5 months Drug: vitamin D3 3000 IU orally daily for 5 months Drug: vitamin D3 5000 IU orally daily for 5 months Drug: Placebo orally daily for 5 months | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study |
- Slope of 25 OH vitamin D3 level vs vitamin D3 dose [ Time Frame: 5 months ]The primary endpoint is the slope of the dose (vitamin D3)- response (25 OH vitamin D3 level) curve for each cohort. The slope of the placebo group will be used to determine changes in 25 OH vitamin D3 levels that are not related to study intervention. The slope will be determined over 5 months.
- slope of vitamin D3 level vs vitamin D3 dose [ Time Frame: 5 months ]slope of vitamin D3 level vs vitamin D3 dose over 5 months
- incidence of hypercalcemia [ Time Frame: 8 months ]incidence of hypercalcemia over 8 months
- incidence of hypercalciuria [ Time Frame: 8 months ]incidence of hypercalciuria over 8 months
- slope of decline of 25 OH vitamin D3 level vs time [ Time Frame: 3 months ]slope of decline of 25 OH vitamin D3 level vs time over 3 months
| Estimated Enrollment: | 1080 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: vitamin D3 1000 IU | Drug: vitamin D3 1000 IU orally daily for 5 months |
| Active Comparator: Vitamin D3 3000 IU | Drug: vitamin D3 3000 IU orally daily for 5 months |
| Active Comparator: Vitamin D3 5000 IU | Drug: vitamin D3 5000 IU orally daily for 5 months |
| Placebo Comparator: Placebo | Drug: Placebo orally daily for 5 months |
Eligibility
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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:
- 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.
- Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.
Contacts and Locations
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): NCT01170507
| 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 |
More Information
| Responsible Party: | Muhammad Maher Hammami, Chairman, Department of Clinical Studies & Empirical Ethics, King Faisal Specialist Hospital & Research Center |
| ClinicalTrials.gov Identifier: | NCT01170507 History of Changes |
| Other Study ID Numbers: |
RAC 2101042 |
| First Submitted: | July 25, 2010 |
| First Posted: | July 27, 2010 |
| Last Update Posted: | August 31, 2016 |
| Last Verified: | August 2016 |
Keywords provided by Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center:
|
vitamin D3, 25 OH vitamin D3 level |
Additional relevant MeSH terms:
|
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamins Vitamin D |
Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |