Vitamin D Supplementation
Conditions
Keywords
vitamin D
Brief summary
This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.
Detailed description
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.
Interventions
DRUGSupplemental Vitamin D
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.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 11-18 years old * healthy
Exclusion criteria
* chronic disease * use of medication known to effect bone or vitamin D metabolism * abnormal vitamin D or calcium at screening * pregnant * body mass index \<5% or \>95%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline 25 Hydroxy Vitamin D (25OHD) Levels | Baseline | 25OHD will be drawn at baseline prior to starting vitamin D supplementation. |
| Follow-up 25OHD Levels | 12 weeks | After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Assessment of Bone Markers | Baseline | Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation |
| Assessment of Bone Markers at Follow-up | 12 weeks | After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Vitamin D Subjects in this arm of the study took 200 IU vit D3 daily. | 25 |
| High Dose Vitamin D Subjects in this arm of the study took 1000 IU vit D3 daily. | 29 |
| Total | 54 |
Baseline characteristics
| Characteristic | High Dose Vitamin D | Low Dose Vitamin D | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 26 Participants | 24 Participants | 50 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Continuous | 16.1 years STANDARD_DEVIATION 2.2 | 16.1 years STANDARD_DEVIATION 2.2 | 16.1 years STANDARD_DEVIATION 2.2 |
| Region of Enrollment United States | 29 participants | 25 participants | 54 participants |
| Sex: Female, Male Female | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Male | 11 Participants | 4 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 29 |
| serious Total, serious adverse events | 0 / 25 | 0 / 29 |
Outcome results
Primary
Baseline 25 Hydroxy Vitamin D (25OHD) Levels
25OHD will be drawn at baseline prior to starting vitamin D supplementation.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose Vitamin D | Baseline 25 Hydroxy Vitamin D (25OHD) Levels | 28.1 ng/ml | Standard Deviation 6.2 |
| High Dose Vitamin D | Baseline 25 Hydroxy Vitamin D (25OHD) Levels | 29 ng/ml | Standard Deviation 7.3 |
Primary
Follow-up 25OHD Levels
After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose Vitamin D | Follow-up 25OHD Levels | 28.9 ng/ml | Standard Deviation 7 |
| High Dose Vitamin D | Follow-up 25OHD Levels | 30.1 ng/ml | Standard Deviation 6.6 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose Vitamin D | Assessment of Bone Markers at Follow-up | 31.1 ug/L | Standard Deviation 31.1 |
| High Dose Vitamin D | Assessment of Bone Markers at Follow-up | 32.3 ug/L | Standard Deviation 32.3 |
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose Vitamin D | Baseline Assessment of Bone Markers | 1.4 ng/ml | Standard Deviation 0.84 |
| High Dose Vitamin D | Baseline Assessment of Bone Markers | 1.74 ng/ml | Standard Deviation 1.09 |