Vitamin A Supplementation at Birth and Atopy in Childhood

NCT01779180 | Unknown

• 1 other identifier: 2013-VAS-Atopy
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopy; Asthma; Eczema; Food Allergy

Keywords

Vitamin A supplementation; BCG vaccination; diphtheria-tetanus-pertussis vaccination; measles vaccination; atopy

Outcome Measures

Primary Outcomes (1)

• Atopic sensitisation

  Skin prick test positivity. A wheal \>=3mm will be considered positive.

  Single observation on day of recruitment

Secondary Outcomes (3)

• Symptoms of asthma

  Single observation on day of recruitment

• Symptoms of eczema

  Single observation on day of recruitment

• Symptoms of food allergy

  Single observation of day of recruitment

Other Outcomes (5)

• Weight

  Single observation on day of recruitment

• Height

  Single observation on day of recruitment

• Mid-upper arm circumference

  Single observation on day of recruitment

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants in a previous neonatal vitamin A supplementation trial

You may qualify if:

• Enrolled at birth in NCT00168610

You may not qualify if:

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

Sponsors & Collaborators

• Bandim Health Project: lead

Study Sites (1)

Bandim Health Project

Bissau, Bissau Codex, 1004, Guinea-Bissau

Location

Related Publications (1)

• Aage S, Kiraly N, Da Costa K, Byberg S, Bjerregaard-Andersen M, Fisker AB, Aaby P, Benn CS. Neonatal vitamin A supplementation associated with increased atopy in girls. Allergy. 2015 Aug;70(8):985-94. doi: 10.1111/all.12641. Epub 2015 May 18.

  PMID: 25939706 DERIVED

MeSH Terms

Conditions

Asthma; Eczema; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Christine Benn, DMSc

  Statens Serum Institut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: November 15, 2013

Record last verified: 2013-02

Locations

GU (1)