Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
This study is currently recruiting participants.
Verified April 2013 by King Faisal Specialist Hospital & Research Center
Sponsor:
King Faisal Specialist Hospital & Research Center
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: April 8, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | July 25, 2010 | ||||
| Last Updated Date | April 8, 2013 | ||||
| Start Date ICMJE | December 2011 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01170494 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels | ||||
| Official Title ICMJE | Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Vitamin D Deficiency | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 800 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Saudi Arabia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01170494 | ||||
| Other Study ID Numbers ICMJE | RAC 2101041 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center | ||||
| Study Sponsor ICMJE | King Faisal Specialist Hospital & Research Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | King Faisal Specialist Hospital & Research Center | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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