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This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.
Vitamin D deficiency is a common problem. Currently, data do not support a recommended vitamin D supplementation dose for health adolescents to maintain normal vitamin D levels. This double blind, randomized controlled 12 week trial compares the use of two supplemental doses of vitamin D in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Vitamin D | Active Comparator | Subjects are randomized to take 200 IU vitamin D3 daily in this arm. |
|
| High Dose Vitamin D | Active Comparator | Subjects are randomized to take 1000 IU vitamin D3 daily in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental Vitamin D | Drug | Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline 25 Hydroxy Vitamin D (25OHD) Levels | 25OHD will be drawn at baseline prior to starting vitamin D supplementation. | Baseline |
| Follow-up 25OHD Levels | After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Assessment of Bone Markers | Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation | Baseline |
| Assessment of Bone Markers at Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Putman, MD | Childrens Hospital, Boston | Principal Investigator |
| Sarah Pitts, MD | Childrens Hospital, Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23608721 | Background | Putman MS, Pitts SA, Milliren CE, Feldman HA, Reinold K, Gordon CM. A randomized clinical trial of vitamin D supplementation in healthy adolescents. J Adolesc Health. 2013 May;52(5):592-8. doi: 10.1016/j.jadohealth.2012.10.270. Epub 2012 Dec 23. |
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Healthy adolescents, ages 11-19 years, were eligible if clinically healthy, likely to comply with treatment, and not vitamin D deficient.
Fifty-six patients were enrolled, and two patients were randomized to a treatment group but did not complete a baseline visit and therefore are not included in the analysis.
Subjects were recruited from the Boston Children's Hospital (BCH) Adolescent Medicine Outpatient Program and from the community via flyers, internet postings, and newspaper advertisements. Enrollment began September 1, 2008 and ended March 18, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Vitamin D | Subjects in this arm of the study took 200 IU vit D3 daily. |
| FG001 | High Dose Vitamin D | Subjects in this arm of the study took 1000 IU vit D3 daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Vitamin D | Subjects in this arm of the study took 200 IU vit D3 daily. |
| BG001 | High Dose Vitamin D | Subjects in this arm of the study took 1000 IU vit D3 daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 subjects were randomized to a treatment group but did not complete the baseline assessment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline 25 Hydroxy Vitamin D (25OHD) Levels | 25OHD will be drawn at baseline prior to starting vitamin D supplementation. | Posted | Mean | Standard Deviation | ng/ml | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Vitamin D | Subjects in this arm of the study took 200 IU vit D3 daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Pitts | Boston Children's Hospital | 617-355-3732 | sarah.pitts@childrens.harvard.edu |
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After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.
| 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Primary | Follow-up 25OHD Levels | After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation. | Posted | Mean | Standard Deviation | ng/ml | 12 weeks |
|
|
|
| Secondary | Baseline Assessment of Bone Markers | Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation | Posted | Mean | Standard Deviation | ng/ml | Baseline |
|
|
|
| Secondary | Assessment of Bone Markers at Follow-up | After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy. | Posted | Mean | Standard Deviation | ug/L | 12 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | High Dose Vitamin D | Subjects in this arm of the study took 1000 IU vit D3 daily. | 0 | 29 | 0 | 29 |
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