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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Nationwide Children's Hospital
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Barbara Gracious, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT02054975
First received: February 3, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.

Condition Intervention
Asthma
Vitamin D Deficiency
Drug: Vitamin D2 + vitamin D3
Drug: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Open Pilot of Low vs. Higher Dose Vitamin D in D-deficient Asthmatic Children: Does Diet Predict Immune Function and Asthma Symptom Response to Vitamin D Supplementation?

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • vitamin D levels [ Time Frame: change in serum vitamin D level from baseline to 12 weeks ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Side Effects Form for Children and Adolescents (SEFCA) [ Time Frame: Baseline, end of week 12 ] [ Designated as safety issue: Yes ]
    structured interviewer-administered questionnaire inquiring about body systems health and concerns

  • Block Kids 2004 Food Frequency Questionnaire [ Time Frame: baseline, and end of week 12 ] [ Designated as safety issue: No ]
    a questionnaire inquiring how often children eat particular items from different food groups

  • immune status [ Time Frame: baseline, and end of week 12 ] [ Designated as safety issue: No ]
    key pro-inflammatory and anti-inflammatory cytokines as well as T-cell ratios will be compared before and after vitamin D supplementation


Other Outcome Measures:
  • asthma severity [ Time Frame: baseline, and end of week 12 ] [ Designated as safety issue: No ]
    via pulmonary function tests

  • quality of life [ Time Frame: Baseline, and end of week 12 ] [ Designated as safety issue: No ]
    pediatric quality of life questionnaire, including questions about asthma

  • omega fatty acid profile [ Time Frame: Baseline, and end of week 12 ] [ Designated as safety issue: No ]
    red blood cells will be analyzed for omega fatty acid percentages and ratios of omega 3 fatty acids will be compared to omega 6 fatty acids.


Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D2 + vitamin D3
Vitamin D2 50,000 IU each week x 4 + vitamin D3 4,000 IU each day for 3 months
Drug: Vitamin D2 + vitamin D3
higher dose vitamin D
Other Names:
  • Vitamin D2 50,000 IU by mouth once per week x 4 weeks
  • Vitamin D3 4,000 IU by mouth once each day
Active Comparator: Vitamin D lower dose
800 IU vitamin D3 by mouth each day for 3 months
Drug: Vitamin D3
lower dose vitamin D
Other Name: Vitamin D3 800 IU by mouth each day for 3 months

Detailed Description:

An estimated up to 120 youth meeting eligibility criteria will be screened for vitamin D deficiency, and if found deficient, will be offered enrollment in this study.

Eligible children who assent and whose parent/guardian consent to participate will be randomized to low dose vs. higher dose vitamin D to take across a 3-month period of time. Blood, questionnaires, and pulmonary function tests will be obtained at baseline and end of study. Weekly phone calls will check on any questions or concerns the participant or their family may have.

Aims and Hypotheses:

Aim I: Evaluate effect sizes for relationships between omega-FA and vitD biomarkers, pre- and post- low and higher dose vitamin D supplementation, in diet, immune function, and asthma severity.

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

Exploratory: Compute effect sizes/odds ratios for differences in pulmonary function, self-reported asthma severity, depressive symptoms, hospitalization/ED visits, and medication changes based on treatment group.

Effect sizes will be calculated for all continuous outcome variables by:

Effect Size (ES) = Average of the post-test scores - Average of the pre-test scores Average standard deviation

Odds ratios for the categorical asthma severity variable will be computed through logistic regression by treatment group with no covariates.

Examine differences in pulmonary function tests, self-reported asthma severity, depressive symptoms, hospitalization/ED visits, and medication changes based on treatment group. Omega fatty acid intake and allergic status will be included as potentially mediating variables.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054975

Contacts
Contact: Barbara L. Gracious, MD 614-722-3066 barbara.gracious@nationwidechildrens.org
Contact: Sandy McBee-Strayer, PhD 614-355-3643 Sandy.McBee-Strayer@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Sandra McBee-Strayer, PhD       sandy.mcbee-strayer@nationwidechildrens.org   
Principal Investigator: Barbara L. Gracious, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
Ohio State University
Investigators
Principal Investigator: Barbara L Gracious, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Barbara Gracious, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02054975     History of Changes
Other Study ID Numbers: IRB13-00504
Study First Received: February 3, 2014
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
asthma, children, vitamin D deficiency, clinical trial

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Asthma
Vitamin D Deficiency
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014