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Effect of Vitamin D Supplementation in Young South African Children Hospitalized With Acute Lower Respiratory Infection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by University of Limpopo.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Siyazi Mda, University of Limpopo
ClinicalTrials.gov Identifier:
NCT02054182
First received: January 18, 2014
Last updated: February 2, 2014
Last verified: January 2014
  Purpose
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.

Condition Intervention Phase
Acute Lower Respiratory Tract Infection
Pneumonia
Bronchiolitis
Drug: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Limpopo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 320
Study Start Date: February 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

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.

  Eligibility

Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054182

Contacts
Contact: Winter-Rose S Nkosi, MBChB +27125214444 czawr@webmail.co.za
Contact: Nolwandle N Duma, MBChB +27125214444 nollyduma@gmail.com

Locations
South Africa
Dr George Mukhari Academic Hospital Not yet recruiting
Pretoria, Gauteng, South Africa, 0204
Contact: Winter-Rose S Nkosi, MBChB    +27125214444    czawr@webmail.co.za   
Contact: Nolwandle N Duma, MBChB    +27125214444    nollyduma@gmail.com   
Principal Investigator: Winter-Rose S Nkosi, MBChB         
Sponsors and Collaborators
University of Limpopo
Investigators
Study Chair: Siyazi Mda, MBChB, PhD Univeristy of Limpopo, Medunsa Campus
  More Information

Responsible Party: Siyazi Mda, Research project supervisor, University of Limpopo
ClinicalTrials.gov Identifier: NCT02054182     History of Changes
Other Study ID Numbers: MREC/M/83/2013:PG
Study First Received: January 18, 2014
Last Updated: February 2, 2014

Keywords provided by University of Limpopo:
vitamin D supplementation, pneumonia, bronchiolitis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Bronchiolitis
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 25, 2017