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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01170507
• Other study ID #: RAC 2101042
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: July 25, 2010
• Last updated: March 6, 2018
• Start date: December 2011
• Est. completion date: August 2016

Study information

• Verified date: March 2018
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 months
Secondary	slope of vitamin D3 level vs vitamin D3 dose	slope of vitamin D3 level vs vitamin D3 dose over 5 months	5 months
Secondary	incidence of hypercalcemia	incidence of hypercalcemia over 8 months	8 months
Secondary	incidence of hypercalciuria	incidence of hypercalciuria over 8 months	8 months
Secondary	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	3 months