NCT01170507

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

Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-12-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2010-07-27
• Last updated: 2018-03-07

Locations

1 site across 1 country: Saudi Arabia