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

Primary Purpose

Type 1 Diabetes, Vitamin D Deficiency/Insufficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Diabetes, Vitamin D, Proinflammatory markers

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Hospital Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Immediate treatment group

Delayed treatment group

Arm Description

This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.

This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.

Outcomes

Primary Outcome Measures

Hemoglobin A1c

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 Outcome Measures

Pro-inflammatory markers

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

Vitamin D level and proinflammatory markers

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

Vitamin D levels on insulin requirements

Correlation between the change of vitamin D levels on insulin requirements

Vitamin D level and HbA1c

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

Baseline differences between vitamin D deficient & sufficient subjects

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

Full Information

NCT ID

NCT01697228

First Posted

September 28, 2012

Last Updated

May 4, 2017

Sponsor

Children's Hospital Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT01697228

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 2012 (Actual)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Hospital Los Angeles

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Vitamin D Deficiency/Insufficiency

Keywords

Diabetes, Vitamin D, Proinflammatory markers

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate treatment group

Arm Type

Other

Arm Description

This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.

Arm Title

Delayed treatment group

Arm Type

Other

Arm Description

This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Primary Outcome Measure Information:

Title

Hemoglobin A1c

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Pro-inflammatory markers

Description

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

Time Frame

6 months

Title

Vitamin D level and proinflammatory markers

Description

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

Time Frame

6 months

Title

Vitamin D levels on insulin requirements

Description

Correlation between the change of vitamin D levels on insulin requirements

Time Frame

6 months

Title

Vitamin D level and HbA1c

Description

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

Time Frame

6 months

Title

Baseline differences between vitamin D deficient & sufficient subjects

Description

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

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roshanak Monzavi, M.D.

Organizational Affiliation

Children's Hospital Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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