Vitamin D in Pediatric Asthma: a Randomized Controlled Open-label Pilot Trial

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot randomized controlled trial of lower vs. higher dose vitamin D supplementation in D-deficient asthmatic children, to determine necessary sample sizes for outcome measures in a larger multisite study, and to examine possible relationships and effect sizes between various biological markers that may be important to the pathophysiology of childhood asthma.

Aims of the study are to:

1. Evaluate effect sizes for relationships between serum 25OH-vitD and omega-fatty acid (FA) biomarkers, before and after supplementation with lower or higher dose vitamin D, on immune function, and asthma severity.

2. Characterize changes in innate and adaptive immune function and inflammatory responses in asthmatic D-deficient youth at baseline and after vitD supplements, by dietary O6:O3FA status and vitD dose.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborator: Ohio State University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 1. Informed consent and assent signed and dated before participation.

• 2. Male or female, ages 8 through 17 at baseline; all races and ethnicities

• 3. asthma and currently taking a prescribed daily inhaled steroid asthma medication

• 4. English-speaking with at least one English-speaking parent

• 5. vitamin D deficiency (<20 ng/mL)

• 6. compliant with attending at least 2/4 of their last asthma-related scheduled clinic visits

Exclusion Criteria:

• 1. If female, pregnant, planning to become pregnant, and/or sexually active and not using reliable contraception

• 2. Unable to provide informed consent (mental retardation, etc)

• 3. Current substance dependence (within the past 2 months)

• 4. Known metabolic bone disease, including rickets

• 5. Known malabsorption disease: Crohn's, ulcerative colitis, celiac sprue

• 6. BMI>40

• 7. Has begun new treatment with vitamin D (>600 IU/day) within the past month

• 8. Treatment with prednisone or other oral or IV steroid within the past 4 weeks

• 9. Taking mineral oil or thiazide diuretics on a daily basis

• 10. Acute or chronic liver, renal, endocrine, neurologic, infectious, autoimmune, cardiac, pulmonary, gastrointestinal, hematologic, metabolic disorder or any other disorder, per study physician judgment.

• 11. Severe treatment noncompliance documented in medical record or by managing provider report.

Our definition of a highly effective method of birth control is consistent with ICH Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (April 1997) when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner. Subjects will also be reminded to use condoms to prevent sexually transmitted diseases and as a second method toward birth control.