Skip to main content
OpenTrials
Completed

NCT Number: NCT01697228

The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM

The investigators are conducting a prospective cross-over study to evaluate the effects of vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to see a significant improvement in glycemic control and a reduction of serum pro-inflammatory markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who are treated with vitamin D.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 13 to 21 years of age, with at least Tanner stage 4 sexual maturity for males or post-menarchal females, and T1DM for at least 1 year. To ensure that inclusion criteria for sexual maturity are met, a physical exam for research purposes will be performed.
  • HbA1c between 7 to 9%
  • Adequate renal function (serum creatinine < 1.5 mg/dL in males and < 1.2 mg/dL in females) and adequate liver function (AST and ALT < 2.5 times the upper limit of normal)
  • Vitamin D insufficiency or deficiency (25-OH vit D level < 30ng/mL) which will be determined on initial screening labs after consenting subjects.

Exclusion criteria

  • Less than 13 or greater than 21 years of age
  • Less than Tanner stage 4 sexual maturity for males or pre-menarche
  • HbA1c less than 7% or greater than 9%
  • T1DM for less than 1 year
  • Vitamin D sufficient (25-OH vit D level > 30 ng/mL)
  • Currently taking any medication that can interfere with vitamin D synthesis or metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin, Anti-tuberculosis drugs
  • Currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids
  • Inadequate renal function (serum creatinine > 1.5mg/dL in males and > 1.2mg/dL in females) or inadequate liver function (AST and ALT > 2.5 times the upper limit of normal)
  • Evidence of malabsorption or short gut.

Treatment and study plan

Vitamin D

Dietary Supplement

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 6 months

    The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months)

Secondary outcomes

  1. Pro-inflammatory markers

    Time frame: 6 months

    Change in pro-inflammatory markers (CRP, IL-6, TNF-α) between treatment and non-treatment periods

  2. Vitamin D level and proinflammatory markers

    Time frame: 6 months

    Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-α

  3. Vitamin D levels on insulin requirements

    Time frame: 6 months

    Correlation between the change of vitamin D levels on insulin requirements

  4. Vitamin D level and HbA1c

    Time frame: 6 months

    Correlation between the change in vitamin D level in the blood and change in HbA1c

  5. Baseline differences between vitamin D deficient & sufficient subjects

    Time frame: Baseline

    Comparison of baseline differences between vitamin D deficient/insufficient subjects and vitamin D sufficient subjects (including pro-inflammatory markers, HbA1c and total daily insulin requirements

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

The Effects of Vitamin D Supplementation on Glycemic Control and Proinflammatory Markers Involved in Microvascular Complications in Adolescents With Type 1 Diabetes.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 2, 2012
Registry last updated
May 8, 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.

Published trials that share one or more normalized conditions with this study.