Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation
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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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]slope of vitamin D3 level vs vitamin D3 dose over 5 months
- incidence of hypercalcemia [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]incidence of hypercalcemia over 8 months
- incidence of hypercalciuria [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]incidence of hypercalciuria over 8 months
- slope of decline of 25 OH vitamin D3 level vs time [ Time Frame: 3 months ] [ Designated as safety issue: No ]slope of decline of 25 OH vitamin D3 level vs time over 3 months
Estimated Enrollment: | 1080 |
Study Start Date: | December 2011 |
Estimated Primary Completion Date: | December 2012 (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 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
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.
Contact: Muhammad M Hammami, MD, PhD | 966 1 442 4527 | muhammad@kfshrc.edu.sa |
Saudi Arabia | |
King Faisal Specialist Hospital & Research Center | Recruiting |
Riyadh, Saudi Arabia, 11211 | |
Contact: Muhammad M Hammami, MD, PhD 966 1 4424527 muhammad@kfshrc.edu.sa | |
Principal Investigator: Muhammad M Hammami, MD, PhD |
Principal Investigator: | Muhammad M Hammami, MD, PhD | King Faisal Specialist Hospital & Research Center |
No publications provided
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 |
Study First Received: | July 25, 2010 |
Last Updated: | December 11, 2011 |
Health Authority: | Saudi Arabia:National Committee of Biological and Medical Ethics |
Keywords provided by 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 Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on October 17, 2012