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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: cholecalciferol 2000 IU orally daily; Drug: ergocalciferol 25000 IU oraly every 2 weeks; Drug: Cholecalciferol 25000 IU orally every 2 weeks; Drug: ergocalciferol 50000 IU orally every 4 weeks; Drug: Cholecalciferol 50000 orally every 4 weeks; Drug: placebo orally everyday; Drug: ergocalciferol 2000 IU orally, daily; Drug: ergocal1000 IU & cholecal 1000 IU orally daily

• Registration Number: NCT01170494
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-25
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Study Start: 2013-02
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D3 2000 IU daily	cholecalciferol 2000 IU orally daily	-
D2 25000 IU Q2wk	ergocalciferol 25000 IU oraly every 2 weeks	-
D3 25000 IU Q2wk	Cholecalciferol 25000 IU orally every 2 weeks	-
D2 50000 IU Q4wk	ergocalciferol 50000 IU orally every 4 weeks	-
D3 50000 IU Q4wk	Cholecalciferol 50000 orally every 4 weeks	-
placebo daily	placebo orally everyday	-
D2 2000 IU daily	ergocalciferol 2000 IU orally, daily	-
D2 1000 IU + D3 1000 IU daily	ergocal1000 IU & cholecal 1000 IU orally daily	-

Primary Outcome Measures

Name	Time	Method
area under the curve of 25 OH vitamin D level	140 days	area under the curve of total 25 OH vitamin D level from day 1 to 140

Secondary Outcome Measures

Name	Time	Method
Cmax of 25 OH vitamin D	140 days	Cmax of total 25 OH vitamin D over the treatment period of 140 days
incidence of hypercalciuria	140 days
Tmax of 25 OH vitamin D level	140 days	Tmax of total 25 OH vitamin D over the treatment period of 140 days
area under the curve of vitamin D level	140 days	area under the curve of total vitamin D level over 140 days
incidence of hypercalcemia	140 days

Trial Locations

Locations (1)

King Faisal Specialist Hospital & research Center; 🇸🇦 Riyadh, Saudi Arabia