The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM
NCT ID: NCT01697228
Last Updated: 2017-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2012-10-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Immediate treatment group
This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.
Vitamin D
Delayed treatment group
This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.
Vitamin D
Interventions
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Vitamin D
Eligibility Criteria
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Inclusion Criteria
3. 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)
4. 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
2. Less than Tanner stage 4 sexual maturity for males or pre-menarche
3. HbA1c less than 7% or greater than 9%
4. T1DM for less than 1 year
5. Vitamin D sufficient (25-OH vit D level \> 30 ng/mL)
6. Currently taking any medication that can interfere with vitamin D synthesis or metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin, Anti-tuberculosis drugs
7. Currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids
8. 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)
9. Evidence of malabsorption or short gut.
13 Years
21 Years
ALL
No
Sponsors
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Children's Hospital Los Angeles
OTHER
Responsible Party
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Roshanak Monzavi MD
Assistant Professor, Center for Endocrinology, Diabetes, and Metabolism
Principal Investigators
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Roshanak Monzavi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Countries
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Other Identifiers
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11-00352
Identifier Type: -
Identifier Source: org_study_id
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