Trial record 4 of 45 for:    vitamin D asthma

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of Limpopo
Sponsor:
Information provided by (Responsible Party):
Siyazi Mda, University of Limpopo
ClinicalTrials.gov Identifier:
NCT02053402
First received: January 21, 2014
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Persistent Asthma
Drug: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin d Supplementation on the Control of Persistent Asthma in Children 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 in peak flow meter reading from baseline to six months, between vitamin D and placebo groups [ Time Frame: From "Day 1" up to until six months of supplementation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Assessment of correlation between vitamin D levels and peak flow meter readings and Asthma Treatment Assessment Questionnaire scores. [ Time Frame: On day 1 ] [ Designated as safety issue: No ]
    Vitamin D levels and peak flow meter readings and Asthma Treatment Assessment Questionnaire scores will be obtained at enrolment. The correlation between vitamin D levels and peak flow meter readings will be evaluated. The correlation between vitamin D levels and Asthma Treatment Assessment Questionnaire scores will also be assessed.

  • Comparison of change from baseline in Asthma Treatment Assessment Questionnaire score at six months, between vitamin D and placebo groups [ Time Frame: From Day 1 up to six months of supplementation ] [ Designated as safety issue: No ]
    Asthma Treatment Assessment Questionnaire (ATAQ). ATAQ includes questions regarding several aspects of asthma management in addition to asthma control, including satisfaction with patient-provider communication, patient attitudes and behaviors, and perceived self-efficacy. The instrument was designed to assist clinicians and health plans with identifying children with poorly controlled asthma who may be candidates for additional asthma-management support. The ATAQ scores will be obtained monthly for six months. The difference in ATAQ scores from baseline enrolment to six months between the two treatment (vitamin D and placebo) groups will be assessed.


Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo to be given daily for six months
Active Comparator: Vitamin D
1200 IU of vitamin D, daily for six months
Drug: Vitamin D
Vitamin D daily for six months
Other Name: Cholecalciferol

Detailed Description:

Some studies have demonstrated a link between Vitamin D deficiency and poor asthma control. Vitamin D has been shown to have an immune modulatory role and plays a role in improving the response to corticosteroids which are the mainstay of treatment in persistent asthma.

A randomized double-blind placebo controlled study will be performed to assess whether vitamin D supplementation will improve control in South African children with persistent asthma at an academic hospital.

The researchers intend to enroll 100 children between the ages of 6 to 12 years with persistent asthma on inhaled therapy. The children will be enrolled from the pediatric outpatient department of Dr George Mukhari Academic Hospital, which is in Pretoria, South Africa. After enrolment, the children will be randomized into one of two groups; one group of 50 children will be given 1200 IU of vitamin and the other group of 50 will receive a placebo. 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 following groups of children will be excluded: children with intermittent asthma symptoms; children whose caregivers refuse to give signed informed consent; children who are not able to use a peak expiratory flow meter and those with concomitant chronic respiratory and/or cardiac conditions.

The vitamin D or placebo will be given in the morning daily to each child for six months. The date when the child was first diagnosed as having asthma will be noted, as well as the date of asthma treatment initiation, and the current treatment at enrolment will be recorded. The children will be asked to come to the hospital for follow up at monthly intervals. At these monthly visits, the children will be evaluated for signs and symptoms of poor asthma control by the study physician. The heights and weights of the children will be measured 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. Treatment adherence will be assessed by counting the pills in the containers by the study physician at the monthly visits. All enrolled children will be required to produce their tablet containers for pill counting.

Data will be analyzed using the IBM SPSS Statistics program. Analysis of variance will be performed in order to compare the difference in ATAQ scores and peak flow meter reading from baseline to six months post intervention between the two groups (vitamin D and placebo).

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

  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: NCT02053402

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

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

No publications provided

Responsible Party: Siyazi Mda, Research project supervisor, University of Limpopo
ClinicalTrials.gov Identifier: NCT02053402     History of Changes
Other Study ID Numbers: MREC/M/82/2013:PG
Study First Received: January 21, 2014
Last Updated: January 30, 2014
Health Authority: United States: Federal Government
South Africa: Department of Health

Keywords provided by University of Limpopo:
vitamin D supplementation, persistent asthma, control

Additional relevant MeSH terms:
Asthma
Ergocalciferols
Vitamin D
Vitamins
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014