Vitamin D Deficiency
Conditions
Keywords
vitamin D3, 25 OH vitamin D3 level
Brief summary
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.
Interventions
DRUGvitamin D3 1000 IU orally daily for 5 months
DRUGvitamin D3 3000 IU orally daily for 5 months
DRUGvitamin D3 5000 IU orally daily for 5 months
DRUGPlacebo orally daily for 5 months
Sponsors
King Faisal Specialist Hospital & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slope of 25 OH vitamin D3 level vs vitamin D3 dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| slope of vitamin D3 level vs vitamin D3 dose | 5 months | slope of vitamin D3 level vs vitamin D3 dose over 5 months |
| incidence of hypercalcemia | 8 months | incidence of hypercalcemia over 8 months |
| incidence of hypercalciuria | 8 months | incidence of hypercalciuria over 8 months |
| slope of decline of 25 OH vitamin D3 level vs time | 3 months | slope of decline of 25 OH vitamin D3 level vs time over 3 months |
Countries
Saudi Arabia
Outcome results
None listed