drugset / Trial / NCT01170507

Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation

NCT01170507

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2011-12
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cholecalciferol Other / unclassified 1000 iu Oral
Comparator Cholecalciferol Other / unclassified 3000 iu Oral
Comparator Cholecalciferol Other / unclassified 5000 iu Oral

Indications