Vitamin D Deficiency Clinical Trial
Official title:
Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study
Verified date | March 2018 |
Source | King Faisal Specialist Hospital & Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Faisal Specialist Hospital & Research Center | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital & Research Center |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Slope of 25 OH vitamin D3 level vs vitamin D3 dose | 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. | 5 months | |
Secondary | slope of vitamin D3 level vs vitamin D3 dose | slope of vitamin D3 level vs vitamin D3 dose over 5 months | 5 months | |
Secondary | incidence of hypercalcemia | incidence of hypercalcemia over 8 months | 8 months | |
Secondary | incidence of hypercalciuria | incidence of hypercalciuria over 8 months | 8 months | |
Secondary | slope of decline of 25 OH vitamin D3 level vs time | slope of decline of 25 OH vitamin D3 level vs time over 3 months | 3 months |
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