Trial Outcomes & Findings for Vitamin D Supplementation in Healthy Adolescents (NCT NCT01126671)

Results Overview

25OHD will be drawn at baseline prior to starting vitamin D supplementation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

Baseline

Results posted on

2018-06-04

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Low Dose Vitamin D Subjects in this arm of the study took 200 IU vit D3 daily.	High Dose Vitamin D Subjects in this arm of the study took 1000 IU vit D3 daily.
Overall Study STARTED	26	30
Overall Study COMPLETED	24	29
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 subjects were randomized to a treatment group but did not complete the baseline assessment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Vitamin D n=25 Participants Subjects in this arm of the study took 200 IU vit D3 daily.	High Dose Vitamin D n=29 Participants Subjects in this arm of the study took 1000 IU vit D3 daily.	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	24 Participants n=5 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.	26 Participants n=7 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.	50 Participants n=5 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.	3 Participants n=7 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.	4 Participants n=5 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.
Age, Categorical >=65 years	0 Participants n=5 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.	0 Participants n=7 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.	0 Participants n=5 Participants • 2 subjects were randomized to a treatment group but did not complete the baseline assessment.
Age, Continuous	16.1 years STANDARD_DEVIATION 2.2 • n=5 Participants	16.1 years STANDARD_DEVIATION 2.2 • n=7 Participants	16.1 years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	29 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

25OHD will be drawn at baseline prior to starting vitamin D supplementation.

Outcome measures

Outcome measures
Measure	Low Dose Vitamin D n=25 Participants Subjects in this arm of the study took 200 IU vit D3 daily.	High Dose Vitamin D n=29 Participants Subjects in this arm of the study took 1000 IU vit D3 daily.
Baseline 25 Hydroxy Vitamin D (25OHD) Levels	28.1 ng/ml Standard Deviation 6.2	29 ng/ml Standard Deviation 7.3

PRIMARY outcome

Timeframe: 12 weeks

After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.

Outcome measures

Outcome measures
Measure	Low Dose Vitamin D n=25 Participants Subjects in this arm of the study took 200 IU vit D3 daily.	High Dose Vitamin D n=29 Participants Subjects in this arm of the study took 1000 IU vit D3 daily.
Follow-up 25OHD Levels	28.9 ng/ml Standard Deviation 7	30.1 ng/ml Standard Deviation 6.6

SECONDARY outcome

Timeframe: Baseline

Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation

Outcome measures

Outcome measures
Measure	Low Dose Vitamin D n=25 Participants Subjects in this arm of the study took 200 IU vit D3 daily.	High Dose Vitamin D n=29 Participants Subjects in this arm of the study took 1000 IU vit D3 daily.
Baseline Assessment of Bone Markers	1.4 ng/ml Standard Deviation 0.84	1.74 ng/ml Standard Deviation 1.09

SECONDARY outcome

Timeframe: 12 weeks

After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.

Outcome measures

Outcome measures
Measure	Low Dose Vitamin D n=25 Participants Subjects in this arm of the study took 200 IU vit D3 daily.	High Dose Vitamin D n=29 Participants Subjects in this arm of the study took 1000 IU vit D3 daily.
Assessment of Bone Markers at Follow-up	31.1 ug/L Standard Deviation 31.1	32.3 ug/L Standard Deviation 32.3

Adverse Events

Low Dose Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Dose Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Pitts

Boston Children's Hospital

Phone: 617-355-3732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place