NCT01697228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

September 28, 2012

Last Update Submit

May 4, 2017

Conditions

Type 1 DiabetesVitamin D Deficiency/Insufficiency

Keywords

DiabetesVitamin DProinflammatory markers

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 months

Secondary Outcomes (5)

  • Pro-inflammatory markers

    6 months

  • Vitamin D level and proinflammatory markers

    6 months

  • Vitamin D levels on insulin requirements

    6 months

  • Vitamin D level and HbA1c

    6 months

  • Baseline differences between vitamin D deficient & sufficient subjects

    Baseline

Study Arms (2)

Immediate treatment group

OTHER

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

Dietary Supplement: Vitamin D

Delayed treatment group

OTHER

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

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT
Delayed treatment groupImmediate treatment group

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Vitamin D DeficiencyDiabetes Mellitus

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Roshanak Monzavi, M.D.

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Center for Endocrinology, Diabetes, and Metabolism

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 2, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

US(1)