Trial Outcomes & Findings for Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements (NCT NCT01029392)

NCT ID: NCT01029392

Last Updated: 2017-04-17

Results Overview

Change in hemoglobin A1c calculated as a percentage change from baseline measurement

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 75 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-04-17

Participant Flow

Blood vitamin D level checked to assign to treatment or no-treatment arm

Participant milestones

Measure	Vitamin D Supplement Those who had a Vit D level of \< 30 ng/mKL Vitamin D: 2000 IU once a day	No Vitamin D Supplementation Screening vitamin D level in normal range for children (50-80 ng.mL)
Overall Study STARTED	37	38
Overall Study COMPLETED	17	27
Overall Study NOT COMPLETED	20	11

Reasons for withdrawal

Measure	Vitamin D Supplement Those who had a Vit D level of \< 30 ng/mKL Vitamin D: 2000 IU once a day	No Vitamin D Supplementation Screening vitamin D level in normal range for children (50-80 ng.mL)
Overall Study Withdrawal by Subject	18	11
Overall Study Physician Decision	2	0

Baseline Characteristics

20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.

Baseline characteristics by cohort

Measure	Those Requiring Vit D Supplement n=37 Participants Those who had a Vit D level of \< 30 Vitamin D: 2000iu once a day	No Vit D Supplementation n=38 Participants Normal vitamin D levels No Vitamin D supplement	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	17 Participants n=17 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.	27 Participants n=27 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.	44 Participants n=44 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.
Age, Categorical Between 18 and 65 years	0 Participants n=17 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.	0 Participants n=27 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.	0 Participants n=44 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.
Age, Categorical >=65 years	0 Participants n=17 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.	0 Participants n=27 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.	0 Participants n=44 Participants • 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.
Age, Continuous	10.4 years STANDARD_DEVIATION 4.2 • n=37 Participants	8.9 years STANDARD_DEVIATION 4.1 • n=38 Participants	9.95 years STANDARD_DEVIATION 4.0 • n=75 Participants
Sex: Female, Male Female	15 Participants n=37 Participants	15 Participants n=38 Participants	30 Participants n=75 Participants
Sex: Female, Male Male	22 Participants n=37 Participants	23 Participants n=38 Participants	45 Participants n=75 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=38 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Asian	1 Participants n=37 Participants	1 Participants n=38 Participants	2 Participants n=75 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=38 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Black or African American	7 Participants n=37 Participants	2 Participants n=38 Participants	9 Participants n=75 Participants
Race (NIH/OMB) White	28 Participants n=37 Participants	31 Participants n=38 Participants	59 Participants n=75 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	1 Participants n=38 Participants	1 Participants n=75 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	3 Participants n=38 Participants	4 Participants n=75 Participants
Region of Enrollment United States	37 participants n=37 Participants	38 participants n=38 Participants	75 participants n=75 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.

Change in hemoglobin A1c calculated as a percentage change from baseline measurement

Outcome measures

Measure	Those Requiring Vit D Supplement n=17 Participants Those who had a Vit D level of \< 30 Vitamin D: 2000iu once a day	No Vitamin D Supplementation n=27 Participants Those with normal vitamin D levels (50-80 ng/mL) No vitamin D supplemenation
Change in Hemoglobin A1c	2.67 percentage change from baseline Standard Deviation 0.58	1.05 percentage change from baseline Standard Deviation 0.58

SECONDARY outcome

Timeframe: 6 months

Population: 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.

Percentage change from baseline number of units of lantus insulin over 6 months.

Outcome measures

Measure	Those Requiring Vit D Supplement n=17 Participants Those who had a Vit D level of \< 30 Vitamin D: 2000iu once a day	No Vitamin D Supplementation n=27 Participants Those with normal vitamin D levels (50-80 ng/mL) No vitamin D supplemenation
Change in Insulin Requirements	2.62 percentage change of baseline insulin Standard Deviation 4.05	1.80 percentage change of baseline insulin Standard Deviation 1.55

Adverse Events

Those Requiring Vit D Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Vit D Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Those Requiring Vit D Supplement n=37 participants at risk Those who had a Vit D level of \< 30 ng/mL Vitamin D: 2000iu once a day	No Vit D Supplementation n=38 participants at risk Normal vitamin D levels (50-80 ng/mL) No vitamin D supplementation
Endocrine disorders Increased dose of Vitamin D needed	0.00% 0/37 • 6 months	0.00% 0/38 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Gerrits

William Beaumont Hospital

Phone: 248-551-0487

Email: peter.gerrits@beaumont.org

Results disclosure agreements

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