Persistent AsthmaPhase 4NCT02053402
Effect of Vitamin D Supplementation on the Control of Asthma in Children at a South African Academic Hospital
A Phase 4 study testing Vitamin D in people with Persistent Asthma, run by University of Limpopo at 1 site in South Africa.
Trial summary
The aim of this randomized double-blind placebo controlled study is to assess whether vitamin D supplementation will improve control in South African children with persistent asthma at an academic hospital. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Persistent Asthma
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2014to Apr 2015
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 12 years with persistent asthma on inhaled therapy, attending the pediatric outpatient department at Dr George Mukhari Academic Hospital in Pretoria, South Africa.
Who cannot join
- Children with intermittent asthma; Children whose caregivers refuse to give signed informed consent; Children who are not able to use a peak expiratory flow meter and those with a concomitant chronic respiratory and/or cardiac condition
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Dr George Mukhari Academic Hospital
Pretoria, Gauteng, 0204
Nolwandle N Duma, MBChB, +27125214444, nollyduma@gmail.com
Winter-Rose S Nkosi, MBChB, +27125214444, czawr@webmail.co.za
About this study
Official title: Effect of Vitamin d Supplementation on the Control of Persistent Asthma in Children at Dr George Mukhari Academic Hospital, Pretoria, South Africa
The aim of this randomized double-blind placebo controlled study is to assess whether vitamin D supplementation will improve control in South African children with persistent asthma at an academic hospital.
The following hypotheses will be tested: Vitamin D significantly and directly correlates with poor control of persistent asthma; Daily vitamin D supplementation for six months will result in improved control of persistent asthma compared to a placebo.
It is intended to enroll 100 children between the ages of 6 to 12 years with persistent asthma on inhaled therapy. The sample size calculations are based on the hypothesis that vitamin D supplementation will result in a 25% improvement in asthma symptoms as measured by the Asthma Treatment Assessment Questionnaire (ATAQ) and peak flow readings. The children will be randomized into one of two groups; one group will be given 1200 IU of vitamin and the other a placebo. The vitamin D or placebo will be given in the morning daily to each child for six months. The children will be assessed monthly by the study physician, to evaluate for signs of poor asthma control e.g. persistent cough and recurrent wheezing. The heights and weights and peak expiratory flow meter readings will also be obtained monthly for six months. Blood samples will be taken for Vitamin D levels, calcium, phosphorus levels at baseline, third month and at the end of the study. All enrolled children will be required to produce their tablet containers for pill counting on a monthly basis to ensure adherence.
Read the detailed description
Some studies have demonstrated a link between Vitamin D deficiency and poor asthma control. Vitamin D has been shown to have an immune modulatory role and plays a role in improving the response to corticosteroids which are the mainstay of treatment in persistent asthma.
A randomized double-blind placebo controlled study will be performed to assess whether vitamin D supplementation will improve control in South African children with persistent asthma at an academic hospital.
The researchers intend to enroll 100 children between the ages of 6 to 12 years with persistent asthma on inhaled therapy. The children will be enrolled from the pediatric outpatient department of Dr George Mukhari Academic Hospital, which is in Pretoria, South Africa. After enrolment, the children will be randomized into one of two groups; one group of 50 children will be given 1200 IU of vitamin and the other group of 50 will receive a placebo. The sample size calculations are based on the hypothesis that vitamin D supplementation will result in a 25% improvement in asthma symptoms as measured by the Asthma Treatment Assessment Questionnaire (ATAQ) and peak flow readings.
The following groups of children will be excluded: children with intermittent asthma symptoms; children whose caregivers refuse to give signed informed consent; children who are not able to use a peak expiratory flow meter and those with concomitant chronic respiratory and/or cardiac conditions.
The vitamin D or placebo will be given in the morning daily to each child for six months. The date when the child was first diagnosed as having asthma will be noted, as well as the date of asthma treatment initiation, and the current treatment at enrolment will be recorded. The children will be asked to come to the hospital for follow up at monthly intervals. At these monthly visits, the children will be evaluated for signs and symptoms of poor asthma control by the study physician. The heights and weights of the children will be measured and peak expiratory flow meter readings will also be obtained monthly for six months. Blood samples will be taken for Vitamin D levels, calcium, phosphorus levels at baseline, third month and at the end of the study. Treatment adherence will be assessed by counting the pills in the containers by the study physician at the monthly visits. All enrolled children will be required to produce their tablet containers for pill counting.
Data will be analyzed using the IBM SPSS Statistics program. Analysis of variance will be performed in order to compare the difference in ATAQ scores and peak flow meter reading from baseline to six months post intervention between the two groups (vitamin D and placebo).
- Conditions
- Persistent Asthma
- Being tested
- Vitamin D
- Keywords
- vitamin D supplementation, persistent asthma, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Cholecalciferol
Vitamin D daily for six months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo to be given daily for six months |
| Vitamin D | Active comparator | 1200 IU of vitamin D, daily for six months Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change in peak flow meter reading from baseline to six months, between vitamin D and placebo groups
Children will be assessed monthly for control of persistent asthma by peak flow meter readings.The peak flow meter readings will be obtained monthly, from each child for six months. The difference in the peak flow meter reading from baseline to six months and between the two treatment groups will be assessed.
Measured: From "Day 1" up to until six months of supplementation
Secondary outcomes (2)
Assessment of correlation between vitamin D levels and peak flow meter readings and Asthma Treatment Assessment Questionnaire scores.
Vitamin D levels and peak flow meter readings and Asthma Treatment Assessment Questionnaire scores will be obtained at enrolment. The correlation between vitamin D levels and peak flow meter readings will be evaluated. The correlation between vitamin D levels and Asthma Treatment Assessment Questionnaire scores will also be assessed.
Measured: On day 1
Comparison of change from baseline in Asthma Treatment Assessment Questionnaire score at six months, between vitamin D and placebo groups
Asthma Treatment Assessment Questionnaire (ATAQ). ATAQ includes questions regarding several aspects of asthma management in addition to asthma control, including satisfaction with patient-provider communication, patient attitudes and behaviors, and perceived self-efficacy. The instrument was designed to assist clinicians and health plans with identifying children with poorly controlled asthma who may be candidates for additional asthma-management support. The ATAQ scores will be obtained monthly for six months. The difference in ATAQ scores from baseline enrolment to six months between the two treatment (vitamin D and placebo) groups will be assessed.
Measured: From Day 1 up to six months of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limpopo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siyazi Mda, University of Limpopo
- Investigators
- Siyazi Mda, MBChB, PhD, Study chair, Univeristy of Limpopo, Medunsa Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053402
- Sponsor's protocol ID
- MREC/M/82/2013:PG
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2014
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin d Supplementation on the Control of Persistent Asthma in Children at Dr George Mukhari Academic Hospital, Pretoria, South Africa
- ClinicalTrials.gov ID
- NCT02053402
- Acronym / sponsor ID
- MREC/M/82/2013:PG
- Conditions
- Persistent Asthma
- Keywords
- vitamin D supplementation, persistent asthma, control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LimpopoUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 3 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.
The aim of this randomized double-blind placebo controlled study is to assess whether vitamin D supplementation will improve control in South African children with persistent asthma at an academic hospital.
The following hypotheses will be tested: Vitamin D significantly and directly correlates with poor control of persistent asthma; Daily vitamin D supplementation for six months will result in improved control of persistent asthma compared to a placebo.
It is intended to enroll 100 children between the ages of 6 to 12 years with persistent asthma on inhaled therapy. The sample size calculations are based on the hypothesis that vitamin D supplementation will result in a 25% improvement in asthma symptoms as measured by the Asthma Treatment Assessment Questionnaire (ATAQ) and peak flow readings. The children will be randomized into one of two groups; one group will be given 1200 IU of vitamin and the other a placebo. The vitamin D or placebo will be given in the morning daily to each child for six months. The children will be assessed monthly by the study physician, to evaluate for signs of poor asthma control e.g. persistent cough and recurrent wheezing. The heights and weights and peak expiratory flow meter readings will also be obtained monthly for six months. Blood samples will be taken for Vitamin D levels, calcium, phosphorus levels at baseline, third month and at the end of the study. All enrolled children will be required to produce their tablet containers for pill counting on a monthly basis to ensure adherence.
Detailed description
Some studies have demonstrated a link between Vitamin D deficiency and poor asthma control. Vitamin D has been shown to have an immune modulatory role and plays a role in improving the response to corticosteroids which are the mainstay of treatment in persistent asthma.
A randomized double-blind placebo controlled study will be performed to assess whether vitamin D supplementation will improve control in South African children with persistent asthma at an academic hospital.
The researchers intend to enroll 100 children between the ages of 6 to 12 years with persistent asthma on inhaled therapy. The children will be enrolled from the pediatric outpatient department of Dr George Mukhari Academic Hospital, which is in Pretoria, South Africa. After enrolment, the children will be randomized into one of two groups; one group of 50 children will be given 1200 IU of vitamin and the other group of 50 will receive a placebo. The sample size calculations are based on the hypothesis that vitamin D supplementation will result in a 25% improvement in asthma symptoms as measured by the Asthma Treatment Assessment Questionnaire (ATAQ) and peak flow readings.
The following groups of children will be excluded: children with intermittent asthma symptoms; children whose caregivers refuse to give signed informed consent; children who are not able to use a peak expiratory flow meter and those with concomitant chronic respiratory and/or cardiac conditions.
The vitamin D or placebo will be given in the morning daily to each child for six months. The date when the child was first diagnosed as having asthma will be noted, as well as the date of asthma treatment initiation, and the current treatment at enrolment will be recorded. The children will be asked to come to the hospital for follow up at monthly intervals. At these monthly visits, the children will be evaluated for signs and symptoms of poor asthma control by the study physician. The heights and weights of the children will be measured and peak expiratory flow meter readings will also be obtained monthly for six months. Blood samples will be taken for Vitamin D levels, calcium, phosphorus levels at baseline, third month and at the end of the study. Treatment adherence will be assessed by counting the pills in the containers by the study physician at the monthly visits. All enrolled children will be required to produce their tablet containers for pill counting.
Data will be analyzed using the IBM SPSS Statistics program. Analysis of variance will be performed in order to compare the difference in ATAQ scores and peak flow meter reading from baseline to six months post intervention between the two groups (vitamin D and placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | –Placebo to be given daily for six months |
| Vitamin D | Active comparator | Drug: Vitamin D1200 IU of vitamin D, daily for six months |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6 to 12 years with persistent asthma on inhaled therapy, attending the pediatric outpatient department at Dr George Mukhari Academic Hospital in Pretoria, South Africa.
Key exclusion criteria (1 listed)
- Children with intermittent asthma; Children whose caregivers refuse to give signed informed consent; Children who are not able to use a peak expiratory flow meter and those with a concomitant chronic respiratory and/or cardiac condition
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 DAlso: CholecalciferolVitamin D daily for six months | Drug | Vitamin D |
Primary outcome
Comparison of change in peak flow meter reading from baseline to six months, between vitamin D and placebo groups
Time frame: From "Day 1" up to until six months of supplementation
Children will be assessed monthly for control of persistent asthma by peak flow meter readings.The peak flow meter readings will be obtained monthly, from each child for six months. The difference in the peak flow meter reading from baseline to six months and between the two treatment groups will be assessed.
2 secondary outcomes
Assessment of correlation between vitamin D levels and peak flow meter readings and Asthma Treatment Assessment Questionnaire scores.
Time frame: On day 1
Comparison of change from baseline in Asthma Treatment Assessment Questionnaire score at six months, between vitamin D and placebo groups
Time frame: From Day 1 up to six months of supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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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.
Siyazi Mda, MBChB, PhD study chair
Univeristy of Limpopo, Medunsa Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Persistent Asthma, run by University of Limpopo at 1 site in South Africa.
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 1 inclusion and 1 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 3 Feb 2014. 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 South Africa. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Nolwandle N Duma, MBChB (+27125214444, nollyduma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change in peak flow meter reading from baseline to six months, between vitamin D and placebo groups (time frame: From "Day 1" up to until six months of supplementation). 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 3 Feb 2014.