Effect of Vitamin D Supplementation in Young South African Children Hospitalized With Acute Lower Respiratory Infection
1 other identifier
interventional
320
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 4, 2014
January 1, 2014
9 months
January 18, 2014
February 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Other Outcomes (1)
Assessment of correlation between vitamin D levels and modified Respiratory Distress Assessment Instrument score
On day 1, i.e. date of randomization
Study Arms (2)
Vitamin D
ACTIVE COMPARATORVitamin D 2 500 IU daily from enrolment until hospital discharge
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Vitamin D 2 500 IU daily from enrolment (within 24 hours of hospitalization) until discharge from hospital
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr George Mukhari Academic Hospital
Pretoria, Gauteng, 0204, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Siyazi Mda, MBChB, PhD
Univeristy of Limpopo, Medunsa Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research project supervisor
Study Record Dates
First Submitted
January 18, 2014
First Posted
February 4, 2014
Study Start
February 1, 2014
Primary Completion
November 1, 2014
Study Completion
January 1, 2015
Last Updated
February 4, 2014
Record last verified: 2014-01