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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by King Faisal Specialist Hospital & Research Center
Sponsor:
Information provided by (Responsible Party):
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01170494
First received: July 25, 2010
Last updated: December 10, 2013
Last verified: December 2013

July 25, 2010
December 10, 2013
December 2011
December 2013   (final data collection date for primary outcome measure)
area under the curve of 25 OH vitamin D level [ Time Frame: 140 days ] [ Designated as safety issue: No ]
area under the curve of total 25 OH vitamin D level from day 1 to 140
Same as current
Complete list of historical versions of study NCT01170494 on ClinicalTrials.gov Archive Site
  • Cmax of 25 OH vitamin D [ Time Frame: 140 days ] [ Designated as safety issue: No ]
    Cmax of total 25 OH vitamin D over the treatment period of 140 days
  • Tmax of 25 OH vitamin D level [ Time Frame: 140 days ] [ Designated as safety issue: No ]
    Tmax of total 25 OH vitamin D over the treatment period of 140 days
  • area under the curve of vitamin D level [ Time Frame: 140 days ] [ Designated as safety issue: No ]
    area under the curve of total vitamin D level over 140 days
  • incidence of hypercalcemia [ Time Frame: 140 days ] [ Designated as safety issue: Yes ]
  • incidence of hypercalciuria [ Time Frame: 140 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vitamin D Deficiency
  • Drug: ergocalciferol 2000 IU orally, daily
    ergocalciferol 2000 IU orally, daily
    Other Name: ergocalciferol
  • Drug: ergocalciferol 25000 IU oraly every 2 weeks
    ergocalciferol 25000 IU oraly every 2 weeks
    Other Name: ergocalciferol
  • Drug: ergocalciferol 50000 IU orally every 4 weeks
    ergocalciferol 50000 IU orally every 4 weeks
    Other Name: ergocalciferol
  • Drug: ergocal1000 IU & cholecal 1000 IU orally daily
    ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day
    Other Name: ergocalciferol and cholecalciferol
  • Drug: cholecalciferol 2000 IU orally daily
    cholecalciferol 2000 IU orally everyday
    Other Name: cholecalciferol
  • Drug: Cholecalciferol 25000 IU orally every 2 weeks
    Cholecalciferol 25000 IU orally every 2 weeks
    Other Name: Cholecalciferol
  • Drug: Cholecalciferol 50000 orally every 4 weeks
    Cholecalciferol 50000 orally every 4 weeks
    Other Name: Cholecalciferol
  • Drug: placebo orally everyday
    placebo orally everyday
    Other Name: placebo
  • Active Comparator: D2 2000 IU daily
    Intervention: Drug: ergocalciferol 2000 IU orally, daily
  • Active Comparator: D3 2000 IU daily
    Intervention: Drug: cholecalciferol 2000 IU orally daily
  • Active Comparator: D2 1000 IU + D3 1000 IU daily
    Intervention: Drug: ergocal1000 IU & cholecal 1000 IU orally daily
  • Active Comparator: D2 25000 IU Q2wk
    Intervention: Drug: ergocalciferol 25000 IU oraly every 2 weeks
  • Active Comparator: D3 25000 IU Q2wk
    Intervention: Drug: Cholecalciferol 25000 IU orally every 2 weeks
  • Active Comparator: D2 50000 IU Q4wk
    Intervention: Drug: ergocalciferol 50000 IU orally every 4 weeks
  • Active Comparator: D3 50000 IU Q4wk
    Intervention: Drug: Cholecalciferol 50000 orally every 4 weeks
  • Placebo Comparator: placebo daily
    Intervention: Drug: placebo orally everyday
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
Not Provided
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact: Muhammad M Hammami, MD, PhD 966 1 442 4527 muhammad@kfshrc.edu.sa
Saudi Arabia
 
NCT01170494
RAC 2101041
No
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
King Faisal Specialist Hospital & Research Center
Not Provided
Principal Investigator: Muhammad M Hammami, MD, PhD King Faisal Specialist Hospital & Research Center
King Faisal Specialist Hospital & Research Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP