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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.
Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin requirements.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Required Vitamin D | Experimental | Those children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation |
|
| Normal Vitamin D | No Intervention | Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | 2000iu once a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Change in hemoglobin A1c calculated as a percentage change from baseline measurement | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin Requirements | Percentage change from baseline number of units of lantus insulin over 6 months. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Gerrits, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WilliamBH | Royal Oak | Michigan | 48073 | United States |
No data sharing.
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Blood vitamin D level checked to assign to treatment or no-treatment arm
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D Supplement | Those who had a Vit D level of < 30 ng/mKL Vitamin D: 2000 IU once a day |
| FG001 | No Vitamin D Supplementation | Screening vitamin D level in normal range for children (50-80 ng.mL) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Those Requiring Vit D Supplement | Those who had a Vit D level of < 30 Vitamin D: 2000iu once a day |
| BG001 | No Vit D Supplementation | Normal vitamin D levels No Vitamin D supplement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin A1c | Change in hemoglobin A1c calculated as a percentage change from baseline measurement | 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed. | Posted | Mean | Standard Deviation | percentage change from baseline | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Those Requiring Vit D Supplement | Those who had a Vit D level of < 30 ng/mL Vitamin D: 2000iu once a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased dose of Vitamin D needed | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Gerrits | William Beaumont Hospital | 248-551-0487 | peter.gerrits@beaumont.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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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).
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| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Insulin Requirements | Percentage change from baseline number of units of lantus insulin over 6 months. | 20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed. | Posted | Mean | Standard Deviation | percentage change of baseline insulin | 6 months |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | No Vit D Supplementation | Normal vitamin D levels (50-80 ng/mL) No vitamin D supplementation | 0 | 38 | 0 | 38 | 0 | 38 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|