AsthmaD-AsthmaNCT02054975
Vitamin D in Pediatric Asthma: a Randomized Controlled Open-label Pilot Trial
A study testing Vitamin D2 + vitamin D3 and Vitamin D3 in people with Asthma and Vitamin D Deficiency, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Asthma, Vitamin D Deficiency
- What is being tested?
- Vitamin D2 + vitamin D3 and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43210
About this study
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?
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.
Read the 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.
- Conditions
- Asthma, Vitamin D Deficiency
- Being tested
- Vitamin D2 + vitamin D3, Vitamin D3
- Keywords
- asthma, children, vitamin D deficiency, clinical trial
- Medical subject headings
- Asthma, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2 + vitamin D3Drug
Also called Vitamin D2 50,000 IU by mouth once per week x 4 weeks, Vitamin D3 4,000 IU by mouth once each day
higher dose vitamin D
Vitamin D3Drug
Also called Vitamin D3 800 IU by mouth each day for 3 months
lower dose vitamin D
| Study group | Role | What they receive |
|---|---|---|
| vitamin D2 + vitamin D3 | Experimental | Vitamin D2 50,000 IU each week x 4 + vitamin D3 4,000 IU each day for 3 months Receives: Drug: Vitamin D2 + vitamin D3 |
| Vitamin D lower dose | Active comparator | 800 IU vitamin D3 by mouth each day for 3 months Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D levels
Primary:
- 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.
Measured: change in serum vitamin D level from baseline to 12 weeks
Secondary outcomes (3)
Side Effects Form for Children and Adolescents (SEFCA)
structured interviewer-administered questionnaire inquiring about body systems health and concerns
Measured: Baseline, end of week 12
Block Kids 2004 Food Frequency Questionnaire
a questionnaire inquiring how often children eat particular items from different food groups
Measured: baseline, and end of week 12
immune status
key pro-inflammatory and anti-inflammatory cytokines as well as T-cell ratios will be compared before and after vitamin D supplementation
Measured: baseline, and end of week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Barbara Gracious, Nationwide Children's Hospital
- Investigators
- Barbara L Gracious, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054975
- Sponsor's protocol ID
- IRB13-00504
- Acronym
- D-Asthma
- Status last verified
- Oct 2015
- First submitted
- 3 Feb 2014
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02054975
- Acronym / sponsor ID
- D-Asthma / IRB13-00504
- Conditions
- Asthma, Vitamin D Deficiency
- Keywords
- asthma, children, vitamin D deficiency, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (estimated)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D2 + vitamin D3 | Experimental | Drug: Vitamin D2 + vitamin D3Vitamin D2 50,000 IU each week x 4 + vitamin D3 4,000 IU each day for 3 months |
| Vitamin D lower dose | Active comparator | Drug: Vitamin D3800 IU vitamin D3 by mouth each day for 3 months |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2 + vitamin D3Also: Vitamin D2 50,000 IU by mouth once per week x 4 weeks, Vitamin D3 4,000 IU by mouth once each dayhigher dose vitamin D | Drug | vitamin D2 + vitamin D3 |
| Vitamin D3Also: Vitamin D3 800 IU by mouth each day for 3 monthslower dose vitamin D | Drug | Vitamin D lower dose |
Primary outcome
vitamin D levels
Time frame: change in serum vitamin D level from baseline to 12 weeks
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.
3 secondary outcomes
Side Effects Form for Children and Adolescents (SEFCA)
Time frame: Baseline, end of week 12
Block Kids 2004 Food Frequency Questionnaire
Time frame: baseline, and end of week 12
immune status
Time frame: baseline, and end of week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara L Gracious, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D2 + vitamin D3 and Vitamin D3 in people with Asthma and Vitamin D Deficiency, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitamin D levels (time frame: change in serum vitamin D level from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.