Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01058720
First received: January 27, 2010
Last updated: February 1, 2011
Last verified: February 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 27, 2010 | ||||
| Last Updated Date | February 1, 2011 | ||||
| Start Date ICMJE | December 2009 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Increment in 25(OH)vitamin D level [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01058720 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Serum Calcium [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] | ||||
| 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 | Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents | ||||
| Official Title ICMJE | A Pilot Study to Evaluate the Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents | ||||
| Brief Summary | The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day. |
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| Detailed Description | Twenty normal weight adolescents between ages 12-18 that are age and gender would receive vitamin D3 supplementation at a dose of 2000 IU/day. Levels of 25(OH)vitamin D would be measured at baseline and after 12 weeks.Relationship between 25 OH vitamin D levels and other demographic variables will be assessed.The primary endpoint in this study is the 25 OH Vitamin D level at 12 weeks. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Vitamin D Deficiency | ||||
| Intervention ICMJE | Dietary Supplement: Vitamin D3
2000 IU orally once daily for 12 weeks |
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| Study Arm (s) | Experimental: Vitamin D3
Patients would receive 2000 IU of vitamin D3 daily for 12 weeks
Intervention: Dietary Supplement: Vitamin D3 |
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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 | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01058720 | ||||
| Other Study ID Numbers ICMJE | 09-004969 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Seema Kumar, MD, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | February 2011 | ||||
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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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