Overview

This trial is active, not recruiting.

Condition vitamin d deficiency
Treatments vitamin d3 1000 iu orally daily for 5 months, vitamin d3 3000 iu orally daily for 5 months, vitamin d3 5000 iu orally daily for 5 months, placebo orally daily for 5 months
Phase phase 1/phase 2
Sponsor King Faisal Specialist Hospital & Research Center
Start date December 2011
End date December 2016
Trial size 1080 participants
Trial identifier NCT01170507, RAC 2101042

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
vitamin d3 1000 iu orally daily for 5 months
(Active Comparator)
vitamin d3 3000 iu orally daily for 5 months
(Active Comparator)
vitamin d3 5000 iu orally daily for 5 months
(Placebo Comparator)
placebo orally daily for 5 months

Primary Outcomes

Measure
Slope of 25 OH vitamin D3 level vs vitamin D3 dose
time frame: 5 months

Secondary Outcomes

Measure
slope of vitamin D3 level vs vitamin D3 dose
time frame: 5 months
incidence of hypercalcemia
time frame: 8 months
incidence of hypercalciuria
time frame: 8 months
slope of decline of 25 OH vitamin D3 level vs time
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study
Principal investigator Muhammad M Hammami, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by King Faisal Specialist Hospital & Research Center.