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OpenTrials
Completed

NCT Number: NCT01029392

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

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

WilliamBH

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy

Treatment and study plan

Vitamin D

Drug

2000iu once a day

Other names: cholecalciferol

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: 6 months

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

Secondary outcomes

  1. Change in Insulin Requirements

    Time frame: 6 months

    Percentage change from baseline number of units of lantus insulin over 6 months.

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study title

Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 10, 2009
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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