AsthmaPhase 1SAVED-PNCT01921894
Vitamin D and Severe Asthma Exacerbations
A Phase 1 study testing Cholecalciferol in people with Asthma, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study of vitamin D is designed to assess both the safety and efficacy of potential doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short period of time (e.g. 4 weeks or less) compared to 200 IU/day. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be at least 6 years of age and younger than 15 years of age
- Have physician-diagnosed asthma
- Taking a medium dose of ICS (e.g. fluticasone 220mcg BID) for daily asthma control for at least 6 months in the prior year.
- Have had a severe asthma exacerbation in the previous year, defined as an Emergency Department (ED) visit, hospitalization, or unscheduled clinic visit for asthma resulting in intramuscular, intravenous, or oral steroids.
- Have bronchodilator responsiveness (BDR, an increase in FEV1 ≥12% from baseline after administration of inhaled albuterol) or (if no BDR) increased airway responsiveness to methacholine challenge
- Have vitamin D insufficiency (a serum vitamin D (25(OH)D) level <30 ng/ml)
- Have his/her parents give voluntary written consent to participate in the study
Who cannot join
- Chronic respiratory disorder other than asthma (e.g., bronchiectasis).
- Severe asthma, as evidenced by any of the following: a) chronic need for medication other than single controller therapy and inhaled β2-agonist, b) intubation for asthma at any time, and c) ≥2 hospitalizations or ≥6 severe asthma exacerbations in the previous year
- History of cigarette smoking in the prior year or former smoking if ≥5 pack-years
- Hepatic or renal disease, metabolic rickets, malabsorptive disorders, or other chronic diseases that would affect vitamin D metabolism
- Immune deficiency, cleft palate or Down's syndrome, which might increase the child's likelihood of respiratory infections
- Treatment with anticonvulsants or pharmacological doses of vitamin D (≥1,000 IU/day of vitamin D2 or D3)
Show all 11Show fewer
- Chronic oral corticosteroid therapy
- Inability to perform acceptable spirometry
- Use of investigational therapies or participation in clinical trials 30 days before or during the duration of the study
- Serum calcium >10.8 mg/dl
- Serum 25(OH) D <10 ng/ml (severe vitamin D deficiency)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Official title: A Phase I Trial for Children With Vitamin D Insufficiency and High Risk of Severe Asthma Exacerbations
This study of vitamin D is designed to assess both the safety and efficacy of potential doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short period of time (e.g. 4 weeks or less) compared to 200 IU/day.
In children with vitamin D insufficiency or deficiency who are at risk for severe asthma exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000 IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day) will result in a larger proportion of subjects achieving this level at 4 and 8 weeks.
Read the detailed description
Asthma is a major public health problem in the United States and worldwide. Severe disease exacerbations account for the majority of costs attributable to asthma in the United States. Vitamin D is an essential nutrient with significant immuno-modulatory effects. The observation that vitamin D insufficiency and asthma share risk factors such as urban residence, obesity, and African American ethnicity has generated significant interest in exploring a link between these two conditions.
This is an 8-week randomized, double-masked, controlled trial of vitamin D3 (2,000 IU/day and 4,000 IU/day) to achieve vitamin D sufficiency (a serum 25(OH)D ≥30 ng/ml in 60 school-aged children (ages 6 to 14 years) who have vitamin D insufficiency (a serum 25(OH)D <30 ng/ml) and are at risk for severe asthma exacerbations, but whose asthma that is well-controlled on medium-dose inhaled corticosteroid (ICS) at the end of a 4-week run-in period.
- Conditions
- Asthma
- Being tested
- Cholecalciferol
- Keywords
- asthma, vitamin D
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called vitamin D3
vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol 4000 IU | Experimental | Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks Receives: Dietary Supplement: Cholecalciferol |
| Cholecalciferol 2000 IU | Experimental | Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks Receives: Dietary Supplement: Cholecalciferol |
| Cholecalciferol 200 IU | Active comparator | Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks Receives: Dietary Supplement: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Measured: 8 weeks
Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation
The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Measured: 4 weeks
Secondary outcomes (3)
Number of Participants With Vitamin D Toxicity
Participants with vitamin D toxicity, hypercalcemia (>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (>0.37)
Measured: 8 weeks
Number of Participants With Elevated Urinary Calcium/Creatinine Ratio
Elevated urinary calcium/creatinine ratio defined as UCa/UCr > 0.37 after either 4 weeks or 8 weeks of supplementation
Measured: 4 and/or 8 weeks
Number of Participants With FEV1 < 80% of Predicted
Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Celedon, MD, University of Pittsburgh
- Investigators
- Juan C Celedon, M.D., Dr.P.H., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921894
- Sponsor's protocol ID
- SAVED-P
- Acronym
- SAVED-P
- Status last verified
- Feb 2017
- First submitted
- 9 Aug 2013
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial for Children With Vitamin D Insufficiency and High Risk of Severe Asthma Exacerbations
- ClinicalTrials.gov ID
- NCT01921894
- Acronym / sponsor ID
- SAVED-P / SAVED-P
- Conditions
- Asthma
- Keywords
- asthma, vitamin D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study of vitamin D is designed to assess both the safety and efficacy of potential doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short period of time (e.g. 4 weeks or less) compared to 200 IU/day.
In children with vitamin D insufficiency or deficiency who are at risk for severe asthma exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000 IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day) will result in a larger proportion of subjects achieving this level at 4 and 8 weeks.
Detailed description
Asthma is a major public health problem in the United States and worldwide. Severe disease exacerbations account for the majority of costs attributable to asthma in the United States. Vitamin D is an essential nutrient with significant immuno-modulatory effects. The observation that vitamin D insufficiency and asthma share risk factors such as urban residence, obesity, and African American ethnicity has generated significant interest in exploring a link between these two conditions.
This is an 8-week randomized, double-masked, controlled trial of vitamin D3 (2,000 IU/day and 4,000 IU/day) to achieve vitamin D sufficiency (a serum 25(OH)D ≥30 ng/ml in 60 school-aged children (ages 6 to 14 years) who have vitamin D insufficiency (a serum 25(OH)D <30 ng/ml) and are at risk for severe asthma exacerbations, but whose asthma that is well-controlled on medium-dose inhaled corticosteroid (ICS) at the end of a 4-week run-in period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol 4000 IU | Experimental | Dietary Supplement: CholecalciferolCholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks |
| Cholecalciferol 2000 IU | Experimental | Dietary Supplement: CholecalciferolCholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks |
| Cholecalciferol 200 IU | Active comparator | Dietary Supplement: CholecalciferolCholecalciferol 200 IU oral chewable tablet once daily for 8 weeks |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Be at least 6 years of age and younger than 15 years of age
- Have physician-diagnosed asthma
- Taking a medium dose of ICS (e.g. fluticasone 220mcg BID) for daily asthma control for at least 6 months in the prior year.
- Have had a severe asthma exacerbation in the previous year, defined as an Emergency Department (ED) visit, hospitalization, or unscheduled clinic visit for asthma resulting in intramuscular, intravenous, or oral steroids.
- Have bronchodilator responsiveness (BDR, an increase in FEV1 ≥12% from baseline after administration of inhaled albuterol) or (if no BDR) increased airway responsiveness to methacholine challenge
Key exclusion criteria (11 listed)
- Chronic respiratory disorder other than asthma (e.g., bronchiectasis).
- Severe asthma, as evidenced by any of the following: a) chronic need for medication other than single controller therapy and inhaled β2-agonist, b) intubation for asthma at any time, and c) ≥2 hospitalizations or ≥6 severe asthma exacerbations in the previous year
- History of cigarette smoking in the prior year or former smoking if ≥5 pack-years
- Hepatic or renal disease, metabolic rickets, malabsorptive disorders, or other chronic diseases that would affect vitamin D metabolism
- Immune deficiency, cleft palate or Down's syndrome, which might increase the child's likelihood of respiratory infections
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 |
|---|---|---|
| CholecalciferolAlso: vitamin D3vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day. | Dietary supplement | Cholecalciferol 200 IU, Cholecalciferol 2000 IU, Cholecalciferol 4000 IU |
Primary outcome
Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation
Time frame: 8 weeks
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation
Time frame: 4 weeks
The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
3 secondary outcomes
Number of Participants With Vitamin D Toxicity
Time frame: 8 weeks
Number of Participants With Elevated Urinary Calcium/Creatinine Ratio
Time frame: 4 and/or 8 weeks
Number of Participants With FEV1 < 80% of Predicted
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Juan C Celedon, M.D., Dr.P.H. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cholecalciferol in people with Asthma, run by University of Pittsburgh 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 23 Mar 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 23 Mar 2017.