|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 September 2016 |
|
Main ID: |
NCT01170494 |
|
Date of registration:
|
25/07/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
|
|
Scientific title:
|
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial |
|
Date of first enrolment:
|
February 2013 |
|
Target sample size:
|
279 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01170494 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Saudi Arabia
| | | | | | | |
|
Contacts
|
|
Name:
|
Muhammad M Hammami, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
King Faisal Specialist Hospital & Research Center |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Vitamin D Deficiency
|
|
Intervention(s)
|
|
Drug: cholecalciferol 2000 IU orally daily
|
|
Drug: ergocalciferol 25000 IU oraly every 2 weeks
|
|
Drug: ergocalciferol 50000 IU orally every 4 weeks
|
|
Drug: Cholecalciferol 50000 orally every 4 weeks
|
|
Drug: Cholecalciferol 25000 IU orally every 2 weeks
|
|
Drug: ergocalciferol 2000 IU orally, daily
|
|
Drug: ergocal1000 IU & cholecal 1000 IU orally daily
|
|
Drug: placebo orally everyday
|
|
Primary Outcome(s)
|
|
area under the curve of 25 OH vitamin D level
[Time Frame: 140 days]
|
|
Secondary Outcome(s)
|
|
Cmax of 25 OH vitamin D
[Time Frame: 140 days]
|
|
area under the curve of vitamin D level
[Time Frame: 140 days]
|
|
incidence of hypercalciuria
[Time Frame: 140 days]
|
|
incidence of hypercalcemia
[Time Frame: 140 days]
|
|
Tmax of 25 OH vitamin D level
[Time Frame: 140 days]
|
|
Secondary ID(s)
|
|
RAC 2101041
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|