Vitamin A Supplementation at Birth and Atopy in Childhood

Asthma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01779180
• Other study ID #: 2013-VAS-Atopy
• Status: Active, not recruiting
• Phase: N/A
• First received: January 28, 2013
• Last updated: November 14, 2013
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2013
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Atopy
• Eczema
• Food Allergy
• Food Hypersensitivity

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau	Bissau Codex

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight		Single observation on day of recruitment	No
Other	Height		Single observation on day of recruitment	No
Other	Mid-upper arm circumference		Single observation on day of recruitment	No
Other	Hospitalisations		Single observation on day of recruitment	No
Other	Infectious diseases	History of chickenpox or measles	Single observation on day of recruitment	No
Primary	Atopic sensitisation	Skin prick test positivity. A wheal >=3mm will be considered positive.	Single observation on day of recruitment	No
Secondary	Symptoms of asthma	Questionnaire based on ISAAC survey for 6-7 year olds	Single observation on day of recruitment	No
Secondary	Symptoms of eczema	Questionnaire based on ISAAC survey for 6-7 year olds	Single observation on day of recruitment	No
Secondary	Symptoms of food allergy	Questionnaire based on Health Nuts survey	Single observation of day of recruitment	No