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

Primary Purpose

Asthma, Vitamin D Deficiency

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin D2 + vitamin D3

Vitamin D3

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, children, vitamin D deficiency, clinical trial

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vitamin D2 + vitamin D3

Vitamin D lower dose

Arm Description

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

800 IU vitamin D3 by mouth each day for 3 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Side Effects Form for Children and Adolescents (SEFCA)

structured interviewer-administered questionnaire inquiring about body systems health and concerns

Block Kids 2004 Food Frequency Questionnaire

a questionnaire inquiring how often children eat particular items from different food groups

immune status

key pro-inflammatory and anti-inflammatory cytokines as well as T-cell ratios will be compared before and after vitamin D supplementation

Full Information

NCT ID

NCT02054975

First Posted

February 3, 2014

Last Updated

October 7, 2015

Sponsor

Nationwide Children's Hospital

Collaborators

Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT02054975

Brief Title

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

Acronym

D-Asthma

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?

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nationwide Children's Hospital

Collaborators

Ohio State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Vitamin D Deficiency

Keywords

asthma, children, vitamin D deficiency, clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vitamin D2 + vitamin D3

Arm Type

Experimental

Arm Description

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

Arm Title

Vitamin D lower dose

Arm Type

Active Comparator

Arm Description

800 IU vitamin D3 by mouth each day for 3 months

Intervention Type

Drug

Intervention Name(s)

Vitamin D2 + vitamin D3

Other Intervention Name(s)

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

Intervention Description

higher dose vitamin D

Intervention Type

Drug

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Vitamin D3 800 IU by mouth each day for 3 months

Intervention Description

lower dose vitamin D

Primary Outcome Measure Information:

Title

vitamin D levels

Description

Time Frame

change in serum vitamin D level from baseline to 12 weeks

Secondary Outcome Measure Information:

Title

Side Effects Form for Children and Adolescents (SEFCA)

Description

structured interviewer-administered questionnaire inquiring about body systems health and concerns

Time Frame

Baseline, end of week 12

Title

Block Kids 2004 Food Frequency Questionnaire

Description

a questionnaire inquiring how often children eat particular items from different food groups

Time Frame

baseline, and end of week 12

Title

immune status

Description

key pro-inflammatory and anti-inflammatory cytokines as well as T-cell ratios will be compared before and after vitamin D supplementation

Time Frame

baseline, and end of week 12

Other Pre-specified Outcome Measures:

Title

asthma severity

Description

via pulmonary function tests

Time Frame

baseline, and end of week 12

Title

quality of life

Description

pediatric quality of life questionnaire, including questions about asthma

Time Frame

Baseline, and end of week 12

Title

omega fatty acid profile

Description

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.

Time Frame

Baseline, and end of week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara L Gracious, MD

Organizational Affiliation

Nationwide Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

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

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