Vitamin A Supplementation at Birth and Atopy in Childhood

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01779180
First received: January 28, 2013
Last updated: November 14, 2013
Last verified: February 2013
  Purpose

INTRODUCTION Eight trials studying the effect of providing neonatal vitamin A supplementation (NVAS) have been reported, and another four are underway to test whether NVAS should become WHO policy. Three of the four African trials were conducted by the Bandim Health Project (BHP) in Guinea-Bissau. One of them was a two-by-two factorial trial among low-birth-weight children. From 2004-2008, the children were randomly allocated to 25,000 IU vitamin A or placebo at birth, and furthermore to BCG vaccination at birth or later as is local policy. In 2011, the investigators conducted a follow-up study. A remarkably strong harmful effect of NVAS on atopy and wheezing was found (manuscript under review).

Seen in the context that NVAS may soon become a WHO policy it is obviously worrying if NVAS is associated with a higher risk of atopy and wheezing. The investigators therefore aim to conduct a similar follow-up study of participants in the first NVAS trial conducted in Guinea-Bissau from 2002-2004, among normal-birth-weight infants, to test whether NVAS is associated with an increased risk of atopy and wheezing and other allergic symptoms as well as growth.

METHODS

Study population:

From 2002-2004 BHP conducted a randomised trial of NVAS. The investigators recruited newborns when they came for BCG vaccination. Provided parental consent, they received an oral supplement of 50,000 IU vitamin A or placebo.

Study design:

This study will be a follow-up study of the cohort of children randomised to NVAS (intervention) or placebo (current policy) together with BCG vaccine at birth.

Other exposures:

The investigators will also investigate the effect of receiving an additional dose of measles vaccine and the timing of DTP vaccine on the development of atopy.

Assessment of outcomes:

The investigators will visit all children at the last known address. Height, weight and mid upper arm circumference will be measured. BCG scar will be examined and vaccination card details recorded by the field assistant. Children will be excluded from skin prick testing (SPT) if they have a history suggestive of anaphylaxis or are currently using anti-histamine medication. SPT will be performed using aero-allergens, food allergens and positive histamine and negative saline control. The mother or guardian will be interviewed by a local assistant. Symptoms of eczema and asthma as well as food allergy will be assessed.

Statistical analysis:

Effect of randomisation group and other factors on outcomes will be analysed in multivariable regression models. All analyses will be adjusted for skin prick tester. All analyses will be conducted stratified by sex.


Condition
Atopy
Asthma
Eczema
Food Allergy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Vitamin A Supplementation at Birth on the Development of Atopy in Childhood: Long-term Follow-up of a Randomised Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Atopic sensitisation [ Time Frame: Single observation on day of recruitment ] [ Designated as safety issue: No ]
    Skin prick test positivity. A wheal >=3mm will be considered positive.


Secondary Outcome Measures:
  • Symptoms of asthma [ Time Frame: Single observation on day of recruitment ] [ Designated as safety issue: No ]
    Questionnaire based on ISAAC survey for 6-7 year olds

  • Symptoms of eczema [ Time Frame: Single observation on day of recruitment ] [ Designated as safety issue: No ]
    Questionnaire based on ISAAC survey for 6-7 year olds

  • Symptoms of food allergy [ Time Frame: Single observation of day of recruitment ] [ Designated as safety issue: No ]
    Questionnaire based on Health Nuts survey


Other Outcome Measures:
  • Weight [ Time Frame: Single observation on day of recruitment ] [ Designated as safety issue: No ]
  • Height [ Time Frame: Single observation on day of recruitment ] [ Designated as safety issue: No ]
  • Mid-upper arm circumference [ Time Frame: Single observation on day of recruitment ] [ Designated as safety issue: No ]
  • Hospitalisations [ Time Frame: Single observation on day of recruitment ] [ Designated as safety issue: No ]
  • Infectious diseases [ Time Frame: Single observation on day of recruitment ] [ Designated as safety issue: No ]
    History of chickenpox or measles


Estimated Enrollment: 2000
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in a previous neonatal vitamin A supplementation trial

Criteria

Inclusion Criteria:

  • Enrolled at birth in NCT00168610

Exclusion Criteria:

  • Children with history suggestive of anaphylaxis will be excluded from skin prick testing but included in the study population
  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: NCT01779180

Locations
Guinea-Bissau
Bandim Health Project
Bissau, Bissau Codex, Guinea-Bissau, 1004
Sponsors and Collaborators
Bandim Health Project
Investigators
Principal Investigator: Christine Benn, DMSc Statens Serum Institut
  More Information

No publications provided

Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01779180     History of Changes
Other Study ID Numbers: 2013-VAS-Atopy
Study First Received: January 28, 2013
Last Updated: November 14, 2013
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
Vitamin A supplementation
BCG vaccination
diphtheria-tetanus-pertussis vaccination
measles vaccination
atopy

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Vitamin A
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014