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

NCT01029392 | Completed Phase 3 Results

• 1 other identifier: 2009-189
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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. 1.Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).
2. 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes; Type I; Newly Diagnosis Type I Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

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

  6 months

Secondary Outcomes (1)

• Change in Insulin Requirements

  6 months

Study Arms (2)

Required Vitamin D

EXPERIMENTAL

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

Drug: Vitamin D

Normal Vitamin D

NO INTERVENTION

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

Interventions

Vitamin D DRUG

2000iu once a day

Also known as: cholecalciferol

Required Vitamin D

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

WilliamBH

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Peter Gerrits
• Organization: William Beaumont Hospital

peter.gerrits@beaumont.org

248-551-0487

Study Officials

• Peter Gerrits, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)