Effect of Vitamin D Supplementation on the Control of Asthma in Children at a South African Academic Hospital

NCT02053402 | Unknown Phase 4

• 1 other identifier: MREC/M/82/2013:PG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Persistent Asthma

Keywords

vitamin D supplementation, persistent asthma, control

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  On day 1

• Comparison of change from baseline in Asthma Treatment Assessment Questionnaire score at six months, between vitamin D and placebo groups

  From Day 1 up to six months of supplementation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo to be given daily for six months

Vitamin D

ACTIVE COMPARATOR

1200 IU of vitamin D, daily for six months

Drug: Vitamin D

Interventions

Vitamin D DRUG

Vitamin D daily for six months

Also known as: Cholecalciferol

Vitamin D

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Limpopo: lead

Study Sites (1)

Dr George Mukhari Academic Hospital

Pretoria, Gauteng, 0204, South Africa

Location

MeSH Terms

Interventions

Vitamin D; Cholecalciferol

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Siyazi Mda, MBChB, PhD

  Univeristy of Limpopo, Medunsa Campus

  STUDY CHAIR

Central Study Contacts

Nolwandle N Duma, MBChB

CONTACT

+27125214444; nollyduma@gmail.com

Winter-Rose S Nkosi, MBChB

CONTACT

+27125214444; czawr@webmail.co.za

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 21, 2014
• First Posted: February 3, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

ZA (1)