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

NCT02054975 | Unknown DMC

• 1 other identifier: IRB13-00504
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Asthma; Vitamin D Deficiency

Keywords

asthma, children, vitamin D deficiency, clinical trial

Outcome Measures

Primary Outcomes (1)

• vitamin D levels

  Primary: 1\. 25-OH vitamin D (D2, D3): 1.0 ml sample sent to Esoterix Laboratory Services (Austin, TX) through NCH and run via high pressure liquid chromatography (HPLC), Tandem Mass Spectrometry analysis. Samples processed individually, not batched, for intervention study purposes.

  change in serum vitamin D level from baseline to 12 weeks

Secondary Outcomes (3)

• Side Effects Form for Children and Adolescents (SEFCA)

  Baseline, end of week 12

• Block Kids 2004 Food Frequency Questionnaire

  baseline, and end of week 12

• immune status

  baseline, and end of week 12

Other Outcomes (3)

• asthma severity

  baseline, and end of week 12

• quality of life

  Baseline, and end of week 12

• omega fatty acid profile

  Baseline, and end of week 12

Study Arms (2)

vitamin D2 + vitamin D3

EXPERIMENTAL

Vitamin D2 50,000 IU each week x 4 + vitamin D3 4,000 IU each day for 3 months

Drug: Vitamin D2 + vitamin D3

Vitamin D lower dose

ACTIVE COMPARATOR

800 IU vitamin D3 by mouth each day for 3 months

Drug: Vitamin D3

Interventions

Vitamin D2 + vitamin D3 DRUG

higher dose vitamin D

Also known as: Vitamin D2 50,000 IU by mouth once per week x 4 weeks, Vitamin D3 4,000 IU by mouth once each day

vitamin D2 + vitamin D3

Vitamin D3 DRUG

lower dose vitamin D

Also known as: Vitamin D3 800 IU by mouth each day for 3 months

Vitamin D lower dose

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Informed consent and assent signed and dated before participation.
• \. Male or female, ages 8 through 17 at baseline; all races and ethnicities
• \. asthma and currently taking a prescribed daily inhaled steroid asthma medication
• \. English-speaking with at least one English-speaking parent
• \. vitamin D deficiency (\<20 ng/mL)
• \. compliant with attending at least 2/4 of their last asthma-related scheduled clinic visits

You may not qualify if:

• \. If female, pregnant, planning to become pregnant, and/or sexually active and not using reliable contraception
• \. Unable to provide informed consent (mental retardation, etc)
• \. Current substance dependence (within the past 2 months)
• \. Known metabolic bone disease, including rickets
• \. Known malabsorption disease: Crohn's, ulcerative colitis, celiac sprue
• \. BMI\>40
• \. Has begun new treatment with vitamin D (\>600 IU/day) within the past month
• \. Treatment with prednisone or other oral or IV steroid within the past 4 weeks
• \. Taking mineral oil or thiazide diuretics on a daily basis
• \. Acute or chronic liver, renal, endocrine, neurologic, infectious, autoimmune, cardiac, pulmonary, gastrointestinal, hematologic, metabolic disorder or any other disorder, per study physician judgment.
• \. 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Ohio State University: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Asthma; Vitamin D Deficiency

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Barbara L Gracious, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 4, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

US (1)