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

NCT ID: NCT01029392

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-06-30

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Required Vitamin D

Those children whose Vitamin D level was low (\<30 ng/mL) are given Vitamin D supplementation

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

2000iu once a day

Normal Vitamin D

Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D

2000iu once a day

Intervention Type: DRUG

Other Intervention Names

cholecalciferol

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Peter Gerrits, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Gerrits, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

WilliamBH

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2009-189

Identifier Type: -

Identifier Source: org_study_id