Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements

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William Beaumont Hospitals

Status and phase

Completed
Phase 3

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT01029392
2009-189

Details and patient eligibility

About

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. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM). 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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Newly diagnosed type I DM.
  • Age <18 years

Exclusion criteria

Pregnancy

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Required Vitamin D
Experimental group
Description:
Those children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation
Treatment:
Drug: Vitamin D
Normal Vitamin D
No Intervention group
Description:
Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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