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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
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.
Time frame: 5 months
slope of vitamin D3 level vs vitamin D3 dose
slope of vitamin D3 level vs vitamin D3 dose over 5 months
Time frame: 5 months
incidence of hypercalcemia
incidence of hypercalcemia over 8 months
Time frame: 8 months
incidence of hypercalciuria
incidence of hypercalciuria over 8 months
Time frame: 8 months
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
Time frame: 3 months
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