Trial Outcomes & Findings for Treatment Study of Vitamin D Deficiency in Adolescents (NCT NCT01784029)

NCT ID: NCT01784029

Last Updated: 2018-10-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 183 participants
• Primary outcome timeframe: Baseline to 3 months
• Results posted on: 2018-10-16

Participant Flow

Patients were recruited aged 13-20 years from the Adolescent Medicine and Pediatric Endocrinology practices at Children's Hospital at Montefiore.

Of the 305 adolescents screened, only 203 met the inclusion criteria of being vitamin D deficient. Of the 203 adolescents identified with vitamin D deficiency, 20 were unable to be further contacted and randomized.

Participant milestones

Measure	Low Dose VItamin D3 1,000 IU 1 x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Weekly High Dose Vitamin D3 50,000 IU 1x week, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Daily High Dose Vitamin D3 5,000 IU 1x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Overall Study STARTED	61	59	63
Overall Study COMPLETED	42	39	41
Overall Study NOT COMPLETED	19	20	22

Reasons for withdrawal

Measure	Low Dose VItamin D3 1,000 IU 1 x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Weekly High Dose Vitamin D3 50,000 IU 1x week, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Daily High Dose Vitamin D3 5,000 IU 1x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Overall Study Lost to Follow-up	19	20	22

Baseline Characteristics

Treatment Study of Vitamin D Deficiency in Adolescents

Baseline characteristics by cohort

Measure	Low Dose n=61 Participants VItamin D3 1,000 IU 1 x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Weekly High Dose n=59 Participants Vitamin D3 50,000 IU 1x week, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Daily High Dose n=63 Participants Vitamin D3 5,000 IU 1x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Total n=183 Participants Total of all reporting groups
Age, Continuous	16.8 years STANDARD_DEVIATION 2.1 • n=5 Participants	16.5 years STANDARD_DEVIATION 2.4 • n=7 Participants	16.6 years STANDARD_DEVIATION 2.1 • n=5 Participants	16.6 years STANDARD_DEVIATION 2.2 • n=4 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	45 Participants n=7 Participants	46 Participants n=5 Participants	136 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	47 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Outcome measures

Measure	Low Dose n=42 Participants VItamin D3 1,000 IU 1 x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Weekly High Dose n=39 Participants Vitamin D3 50,000 IU 1x week, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.	Daily High Dose n=41 Participants Vitamin D3 5,000 IU 1x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL)	6.2 ng/mL Standard Deviation 6.5	24.9 ng/mL Standard Deviation 15.1	21 ng/mL Standard Deviation 15.2

Adverse Events

Low Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Weekly High Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Daily High Dose

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

Hina Talib

Children's Hospital at Montefiore

Phone: 718-920-6781

Email: htalib@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place