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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Gerrits, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01029392
First received: December 9, 2009
Last updated: March 3, 2017
Last verified: December 2016
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus Drug: Vitamin D Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study

Resource links provided by NLM:


Further study details as provided by Peter Gerrits, MD, William Beaumont Hospitals:

Primary Outcome Measures:
  • Change in Hemoglobin A1c [ Time Frame: 6 months ]
    Change in hemoglobin A1c calculated as a percentage change from baseline measurement


Secondary Outcome Measures:
  • Change in Insulin Requirements [ Time Frame: 6 months ]
    Percentage change from baseline number of units of lantus insulin over 6 months.


Enrollment: 75
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Required Vitamin D
Those children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation
Drug: Vitamin D
2000iu once a day
Other Name: cholecalciferol
No Intervention: Normal Vitamin D
Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation

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.
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029392

Locations
United States, Michigan
WilliamBH
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Peter Gerrits, MD William Beaumont Hospitals
  More Information

Responsible Party: Peter Gerrits, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01029392     History of Changes
Other Study ID Numbers: 2009-189
Study First Received: December 9, 2009
Results First Received: December 13, 2016
Last Updated: March 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data sharing.

Keywords provided by Peter Gerrits, MD, William Beaumont Hospitals:
Diabetes
Type I
Newly Diagnosis Type I Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 21, 2017