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Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels

Information source: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitamin D Deficiency

Intervention: ergocalciferol 2000 IU orally, daily (Drug); ergocalciferol 25000 IU oraly every 2 weeks (Drug); ergocalciferol 50000 IU orally every 4 weeks (Drug); ergocal1000 IU & cholecal 1000 IU orally daily (Drug); cholecalciferol 2000 IU orally daily (Drug); Cholecalciferol 25000 IU orally every 2 weeks (Drug); Cholecalciferol 50000 orally every 4 weeks (Drug); placebo orally everyday (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: King Faisal Specialist Hospital & Research Center

Official(s) and/or principal investigator(s):
Muhammad M Hammami, MD, PhD, Principal Investigator, Affiliation: King Faisal Specialist Hospital & Research Center

Overall contact:
Muhammad M Hammami, MD, PhD, Phone: 966 1 442 4527, Email: muhammad@kfshrc.edu.sa

Summary

Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level. The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.

Clinical Details

Official title: Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: area under the curve of 25 OH vitamin D level

Secondary outcome:

Cmax of 25 OH vitamin D

Tmax of 25 OH vitamin D level

area under the curve of vitamin D level

incidence of hypercalcemia

incidence of hypercalciuria

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy 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.

- 25 OH vitamin D level between 20 to 50 nmol/L.

Locations and Contacts

Muhammad M Hammami, MD, PhD, Phone: 966 1 442 4527, Email: muhammad@kfshrc.edu.sa

King Faisal Specialist Hospital & research Center, Riyadh 11211, Saudi Arabia; Recruiting
Additional Information

Starting date: December 2011
Last updated: March 31, 2015

Page last updated: August 23, 2015

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