Effect of Vitamin D Supplementation in Young South African Children Hospitalized With Acute Lower Respiratory Infection
|ClinicalTrials.gov Identifier: NCT02054182|
Recruitment Status : Unknown
Verified January 2014 by Siyazi Mda, University of Limpopo.
Recruitment status was: Not yet recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Lower Respiratory Tract Infection Pneumonia Bronchiolitis||Drug: Vitamin D||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||January 2015|
Active Comparator: Vitamin D
Vitamin D 2 500 IU daily from enrolment until hospital discharge
Drug: Vitamin D
Vitamin D 2 500 IU daily from enrolment (within 24 hours of hospitalization) until discharge from hospital
Other Name: Cholecalciferol
Placebo Comparator: Placebo
- 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.
- 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 ]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.
- Assessment of correlation between vitamin D levels and modified Respiratory Distress Assessment Instrument score [ Time Frame: On day 1, i.e. date of randomization ]Blood for vitamin D levels will be obtained at enrolment and this will be used to assess whether a child is vitamin D deficient. Severity of ALRTI symptoms will also be assessed at enrolment using the modified RDAI. The correlation between vitamin D deficiency and severity of symptoms will be assessed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054182
|Contact: Winter-Rose S Nkosi, MBChBemail@example.com|
|Contact: Nolwandle N Duma, MBChBfirstname.lastname@example.org|
|Dr George Mukhari Academic Hospital||Not yet recruiting|
|Pretoria, Gauteng, South Africa, 0204|
|Contact: Winter-Rose S Nkosi, MBChB +27125214444 email@example.com|
|Contact: Nolwandle N Duma, MBChB +27125214444 firstname.lastname@example.org|
|Principal Investigator: Winter-Rose S Nkosi, MBChB|
|Study Chair:||Siyazi Mda, MBChB, PhD||Univeristy of Limpopo, Medunsa Campus|