Back to resultsEfficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Supplementation, Adolescence
Eligibility Criteria
Inclusion criteria:
- Subjects between ages 12 and 18 years with BMI between the 5th and the 85th percentile for age and gender.
Exclusion Criteria:
- Subjects with 25 (OH)- D levels >80 ng/mL
- Serum calcium >10.8 mg/dL
- Serum phosphorus > 5.5 mg/dl
- Pregnancy or nursing
- Current cancer
- Patients on multivitamin supplementation
- Dietary calcium intake exceeding 1500 mg/day
- Hepatic or renal disorders
- Type 1 or Type 2 diabetes mellitus
- Those receiving insulin, metformin, or oral hypoglycemic medications
- Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vitamin D3
Arm Description
Patients would receive 2000 IU of vitamin D3 daily for 12 weeks
Outcomes
Primary Outcome Measures
Increment in 25(OH)vitamin D level
Secondary Outcome Measures
Serum Calcium
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01058720
Brief Title
Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
Official Title
A Pilot Study to Evaluate the Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D, Supplementation, Adolescence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3
Arm Type
Experimental
Arm Description
Patients would receive 2000 IU of vitamin D3 daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
2000 IU orally once daily for 12 weeks
Primary Outcome Measure Information:
Title
Increment in 25(OH)vitamin D level
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Serum Calcium
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Subjects between ages 12 and 18 years with BMI between the 5th and the 85th percentile for age and gender.
Exclusion Criteria:
Subjects with 25 (OH)- D levels >80 ng/mL
Serum calcium >10.8 mg/dL
Serum phosphorus > 5.5 mg/dl
Pregnancy or nursing
Current cancer
Patients on multivitamin supplementation
Dietary calcium intake exceeding 1500 mg/day
Hepatic or renal disorders
Type 1 or Type 2 diabetes mellitus
Those receiving insulin, metformin, or oral hypoglycemic medications
Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seema Kumar, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
We'll reach out to this number within 24 hrs