Type 1 Diabetes Mellitus
Conditions
Keywords
Diabetes, Type I, Newly Diagnosis Type I Diabetes Mellitus
Brief summary
Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods. 1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM). 2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level over the past few months) and document insulin requirements before and after vitamin supplementation is given. Hypothesis: Maintaining vitamin D levels \>30 ng/ml will decrease HbA1c and insulin requirements.
Detailed description
New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the Pediatric Endocrine Clinic will be approached about the study at their presentation and time will be given for the patient and family to discuss and ask questions regarding the study. Patients will then be enrolled following informed consent. Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks from the point of diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA cream to anesthetize the area will be used prior to blood draw. A vitamin D level of \<30 ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks again for another 3 months.
Interventions
DRUGVitamin D
2000iu once a day
Sponsors
Corewell Health East
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Patients with clinically significantly low Vitamin D levels (\<30 ng/mL) were supplemented with Vitamin D and compared to patients with normal vitamin D levels (50-80 nG/mL).
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed type I DM. * Age \<18 years
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | 6 months | Change in hemoglobin A1c calculated as a percentage change from baseline measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Requirements | 6 months | Percentage change from baseline number of units of lantus insulin over 6 months. |
Countries
United States
Participant flow
Pre-assignment details
Blood vitamin D level checked to assign to treatment or no-treatment arm
Participants by arm
| Arm | Count |
|---|---|
| Those Requiring Vit D Supplement Those who had a Vit D level of \< 30
Vitamin D: 2000iu once a day | 37 |
| No Vit D Supplementation Normal vitamin D levels No Vitamin D supplement | 38 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 18 | 11 |
Baseline characteristics
| Characteristic | No Vit D Supplementation | Total | Those Requiring Vit D Supplement |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 44 Participants | 17 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.9 years STANDARD_DEVIATION 4.1 | 9.95 years STANDARD_DEVIATION 4 | 10.4 years STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 31 Participants | 59 Participants | 28 Participants |
| Region of Enrollment United States | 38 participants | 75 participants | 37 participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 23 Participants | 45 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 38 |
| other Total, other adverse events | 0 / 37 | 0 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 |
Outcome results
Primary
Change in Hemoglobin A1c
Change in hemoglobin A1c calculated as a percentage change from baseline measurement
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Those Requiring Vit D Supplement | Change in Hemoglobin A1c | 2.67 percentage change from baseline | Standard Deviation 0.58 |
| No Vitamin D Supplementation | Change in Hemoglobin A1c | 1.05 percentage change from baseline | Standard Deviation 0.58 |
Secondary
Change in Insulin Requirements
Percentage change from baseline number of units of lantus insulin over 6 months.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Those Requiring Vit D Supplement | Change in Insulin Requirements | 2.62 percentage change of baseline insulin | Standard Deviation 4.05 |
| No Vitamin D Supplementation | Change in Insulin Requirements | 1.80 percentage change of baseline insulin | Standard Deviation 1.55 |