Trial Outcomes & Findings for Effect of Vitamin D on the Honeymoon Period in Children and Adolescents With Type 1 Diabetes (NCT NCT01724190)

NCT ID: NCT01724190

Last Updated: 2024-02-28

Results Overview

Our primary outcome measure will be to determine the rate of partial clinical remission at 9 months of disease duration, which will be assessed by determining insulin dose adjusted hemoglobin A1c (IDAA1c) using the formula (HbA1c% + \[4 x insulin dose u/kg/day\]). A IDAA1c \<9 will be indicative of partial clinical remission.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 9 months disease duration
• Results posted on: 2024-02-28

Participant Flow

Participant milestones

Measure	Vitamin D Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months. Vitamin D	Placebo Subjects will receive a placebo solution daily over the course of 9 months. Placebo
Overall Study STARTED	19	18
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Vitamin D on the Honeymoon Period in Children and Adolescents With Type 1 Diabetes

Baseline characteristics by cohort

Measure	Vitamin D n=15 Participants Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months. Vitamin D	Placebo n=14 Participants Subjects will receive a placebo solution daily over the course of 9 months. Placebo	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9.875 years STANDARD_DEVIATION 2.59 • n=5 Participants	11.6 years STANDARD_DEVIATION 3.28 • n=7 Participants	10.7 years STANDARD_DEVIATION 3.04 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months disease duration

Our primary outcome measure will be to determine the rate of partial clinical remission at 9 months of disease duration, which will be assessed by determining insulin dose adjusted hemoglobin A1c (IDAA1c) using the formula (HbA1c% + [4 x insulin dose u/kg/day]). A IDAA1c <9 will be indicative of partial clinical remission.

Outcome measures

Measure	Vitamin D n=15 Participants Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months. Vitamin D	Placebo n=14 Participants Subjects will receive a placebo solution daily over the course of 9 months. Placebo
IDAA1c	5 Participants	2 Participants

Adverse Events

Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Kathryn Obrynba

Nationwide Childrens Hospital

Phone: 6147224425

Email: kathryn.obrynba@nationwidechidrens.org

Results disclosure agreements

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