Acute Lower Respiratory Tract InfectionPhase 4NCT02054182
Effect of Vitamin D Supplementation in Young South African Children Hospitalized With Acute Lower Respiratory Infection
A Phase 4 study testing Vitamin D in people with Acute Lower Respiratory Tract Infection and Pneumonia, run by University of Limpopo at 1 site in South Africa.
Trial summary
The purpose of this study is to determine whether vitamin D supplements given to children aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will improve symptoms and reduce the duration of hospitalization. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Acute Lower Respiratory Tract Infection, Pneumonia, Bronchiolitis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2014to Jan 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children age 1month - 5 yrs, admitted in the paediatric unit of Dr George Mukhari Hospital with an acute lower respiratory tract infection i.e. bronchiolitis and/ or pneumonia
Who cannot join
- Children whose caregivers decline participation in the study Children with co-morbid chronic respiratory condition(s) Children who have received vitamin D supplementation in the past 30 days
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Dr George Mukhari Academic Hospital
Pretoria, Gauteng, 0204
Winter-Rose S Nkosi, MBChB, +27125214444, czawr@webmail.co.za
Nolwandle N Duma, MBChB, +27125214444, nollyduma@gmail.com
About this study
Official title: Effect of Vitamin D Supplementation in Young Children With Acute Lower Respiratory Tract Infection at Dr George Mukhari Academic Hospital, Pretoria, South Africa
The purpose of this study is to determine whether vitamin D supplements given to children aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will improve symptoms and reduce the duration of hospitalization.
Read the detailed description
In a randomized, double blind placebo controlled interventional study, children aged 1 month to 5 years, who are admitted with acute lower respiratory tract infection (ALRTI) to Dr George Mukhari Academic Hospital will be enrolled. The children will randomized to receive 2500 IU of vitamin D or a placebo. It is intended to enrol 320 children, 160 to receive vitamin D and the other 160 to receive a placebo. This sample size was calculated at 80% power and 5% significance. The children will be enrolled within 24 hours of admission and the intervention (supplement or placebo) will be daily until the child is discharged fron the hospital.
The severity of ALRTI will be assessed using the modified Respiratory Distress Assessment Instrument (MRDAI) score. The thorough physical examination and classification of severity of the symptoms will be done at enrolment and daily until hospital discharge.
Blood samples for vitamin D and calcium concentrations will be assessed at enrolment, before the child is given the supplement or placebo.
The difference in the improvement in MRDAI score between the placebo and the supplement will be assessed by analysis of variance (ANOVA). Similarly the difference in duration of hospital stay between the two groups will also be analysed using ANOVA. The association between the vitamin D levels and the MRDAI score on admission will also be assessed and analysed using ANOVA.
All eligible children will be sequentially enrolled until the desired sample size is reached. A simple randomisation by means of computer generated numbers will be used to minimize selection bias. Both the study subjects and the investigators will be blinded to the allocation (treatment or placebo). The unblinding will be done only after the analysis has been completed.
- Being tested
- Vitamin D
- Keywords
- vitamin D supplementation, pneumonia, bronchiolitis
- Medical subject headings
- Pneumonia, Bronchiolitis
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 2 500 IU daily from enrolment (within 24 hours of hospitalization) until discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Vitamin D 2 500 IU daily from enrolment until hospital discharge Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change from baseline in modified Respiratory Distress Assessment Instrument score at hospital discharge between vitamin D supplement and placebo groups.
The modified Respiratory Distress Assessment Instrument score, involves the measurement of the child's respiratory rate, assessment of the use of accessory muscles, the child's color, and auscultatory findings; each of these is given a score from 0 to 3. The higher the score the more severe the clinical condition. This scoring system has been validated in a number of scientific studies.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes (1)
Comparison of duration of hospitalization between vitamin D supplementation and placebo groups.
The duration of hospital stay will be calculated from the day of admission to the day the child is assessed and deemed fit for discharge by the attending physician. All children at discharge will have a modified RDAI score of less than 3.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
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 startFeb 2014
- Primary completionNov 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lower Respiratory Tract InfectionStudies 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
- 320 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
- NCT02054182
- Sponsor's protocol ID
- MREC/M/83/2013:PG
- Status last verified
- Jan 2014
- First submitted
- 18 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation in Young Children With Acute Lower Respiratory Tract Infection at Dr George Mukhari Academic Hospital, Pretoria, South Africa
- ClinicalTrials.gov ID
- NCT02054182
- Acronym / sponsor ID
- MREC/M/83/2013:PG
- Keywords
- vitamin D supplementation, pneumonia, bronchiolitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of LimpopoUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Jan 2015 (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.
The purpose of this study is to determine whether vitamin D supplements given to children aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will improve symptoms and reduce the duration of hospitalization.
Detailed description
In a randomized, double blind placebo controlled interventional study, children aged 1 month to 5 years, who are admitted with acute lower respiratory tract infection (ALRTI) to Dr George Mukhari Academic Hospital will be enrolled. The children will randomized to receive 2500 IU of vitamin D or a placebo. It is intended to enrol 320 children, 160 to receive vitamin D and the other 160 to receive a placebo. This sample size was calculated at 80% power and 5% significance. The children will be enrolled within 24 hours of admission and the intervention (supplement or placebo) will be daily until the child is discharged fron the hospital.
The severity of ALRTI will be assessed using the modified Respiratory Distress Assessment Instrument (MRDAI) score. The thorough physical examination and classification of severity of the symptoms will be done at enrolment and daily until hospital discharge.
Blood samples for vitamin D and calcium concentrations will be assessed at enrolment, before the child is given the supplement or placebo.
The difference in the improvement in MRDAI score between the placebo and the supplement will be assessed by analysis of variance (ANOVA). Similarly the difference in duration of hospital stay between the two groups will also be analysed using ANOVA. The association between the vitamin D levels and the MRDAI score on admission will also be assessed and analysed using ANOVA.
All eligible children will be sequentially enrolled until the desired sample size is reached. A simple randomisation by means of computer generated numbers will be used to minimize selection bias. Both the study subjects and the investigators will be blinded to the allocation (treatment or placebo). The unblinding will be done only after the analysis has been completed.
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 |
|---|---|---|
| Vitamin D | Active comparator | Drug: Vitamin DVitamin D 2 500 IU daily from enrolment until hospital discharge |
| Placebo | Placebo comparator | –Placebo |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children age 1month - 5 yrs, admitted in the paediatric unit of Dr George Mukhari Hospital with an acute lower respiratory tract infection i.e. bronchiolitis and/ or pneumonia
Key exclusion criteria (1 listed)
- Children whose caregivers decline participation in the study Children with co-morbid chronic respiratory condition(s) Children who have received vitamin D supplementation in the past 30 days
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 2 500 IU daily from enrolment (within 24 hours of hospitalization) until discharge from hospital | Drug | Vitamin D |
Primary outcome
Comparison of change from baseline in modified Respiratory Distress Assessment Instrument score at hospital discharge between vitamin D supplement and placebo groups.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
The modified Respiratory Distress Assessment Instrument score, involves the measurement of the child's respiratory rate, assessment of the use of accessory muscles, the child's color, and auscultatory findings; each of these is given a score from 0 to 3. The higher the score the more severe the clinical condition. This scoring system has been validated in a number of scientific studies.
1 secondary outcome
Comparison of duration of hospitalization between vitamin D supplementation and placebo groups.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
Related trials for Acute Lower Respiratory Tract Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
Not yet recruitingObservational study
Neutrophil Monocyte Lymphocyte Ratios in Pediatric Chest Infections
Pneumonia, Bronchiolitis
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
Not yet recruitingPhase 1
Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine （CHO Cell） in Adults Aged 18 Years and Older
Respiratory Syncytial Virus (RSV)
Active, not recruitingObservational study
Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants
Respiratory Syncytial Virus (RSV)
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 Acute Lower Respiratory Tract Infection and Pneumonia, 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 4 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 Winter-Rose S Nkosi, MBChB (+27125214444, czawr@webmail.co.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change from baseline in modified Respiratory Distress Assessment Instrument score at hospital discharge between vitamin D supplement and placebo groups. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days). 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 4 Feb 2014.