Impact of the WHO Recommended Vitamin A Supplementation at Immunisation Contacts

NCT00514891 | Terminated Phase 4 DMC

• 1 other identifier: CVK-2006-7041-99
• Study Type: interventional
• Target: 9,500
• Locations: 1 country
• Sites: 1

Brief Summary

High-dose vitamin A to children above 6 months of age reduces all-cause mortality by 23-30%. The WHO recommends vitamin A supplementation (VAS) with the first vaccine after 6 months of age. However, the effect of providing VAS with vaccines has never been investigated. We have hypothesised that the effect of VAS depends on the immune stimulus at the time of supplementation. Hence, the effect might vary depending on which type of vaccine it is given with. In particular, we hypothesised that VAS might be beneficial when given with measles vaccine but not when given with DTP vaccine. Normally the first vaccine after 6 months of age would be a measles vaccine, but many children come late for their DTP vaccinations and receive DTP alone or together with measles vaccine. Hence, it is important to study whether the effect of VAS is the same irrespective of the vaccine(s) administered at the same time. Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with vaccines, but plans to do so within the next years. Together with the Ministry of Health in Guinea-Bissau, the Bandim Health Project (BHP) in Guinea-Bissau will investigate the effect on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau. This will be done in a large randomised trial. BHP has a demographic surveillance system (DSS) which has followed a population of now more than 150,000 individuals for almost 30 years. Children will be randomised to receive VAS or placebo with their first vaccine after 6 months of age, and will be followed through the DSS to assess mortality and morbidity. Based on previous observations, the effects of VAS might differ according to sex and season. The interaction between VAS, sex, and season will also be studied in the present trial. By identifying situations where VAS may be beneficial, ineffective, or even harmful the study may contribute importantly to optimising the VAS policy for low-income countries.

Conditions

Mortality; Morbidity

Outcome Measures

Primary Outcomes (1)

• Mortality, morbidity

  1 year

Secondary Outcomes (1)

• Growth, Vitamin A status, Immunology

Study Arms (2)

1

ACTIVE COMPARATOR

Vitamin A supplementation

Biological: Vitamin A

2

PLACEBO COMPARATOR

Placebo

Biological: Vitamin A

Interventions

Vitamin A BIOLOGICAL

The effect of vitamin A given with different vaccines will be studied

1; 2

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Urban area: 6-17-month-old children, presenting for vaccination at a health centre in the study area.
• Rural area: 6-23-month-old children who are missing one or more routine vaccinations when visited by our mobile team.

You may not qualify if:

• Normally applied contraindications for receiving vaccinations, including high fever.
• VAS within last month.

Sponsors & Collaborators

• Bandim Health Project: lead
• Ministry of Health, Guinea-Bissau: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Bandim Health Project, Apartado 861

Bissau, Guinea-Bissau

Location

Related Publications (3)

• Fisker AB, Bale C, Rodrigues A, Balde I, Fernandes M, Jorgensen MJ, Danneskiold-Samsoe N, Hornshoj L, Rasmussen J, Christensen ED, Bibby BM, Aaby P, Benn CS. High-dose vitamin A with vaccination after 6 months of age: a randomized trial. Pediatrics. 2014 Sep;134(3):e739-48. doi: 10.1542/peds.2014-0550.

  PMID: 25136048 DERIVED

• Fisker AB, Bale C, Jorgensen MJ, Balde I, Hornshoj L, Bibby BM, Aaby P, Benn CS. High-dose vitamin A supplementation administered with vaccinations after 6 months of age: sex-differential adverse reactions and morbidity. Vaccine. 2013 Jun 28;31(31):3191-8. doi: 10.1016/j.vaccine.2013.04.072. Epub 2013 May 14.

  PMID: 23680441 DERIVED

• Danneskiold-Samsoe N, Fisker AB, Jorgensen MJ, Ravn H, Andersen A, Balde ID, Leo-Hansen C, Rodrigues A, Aaby P, Benn CS. Determinants of vitamin a deficiency in children between 6 months and 2 years of age in Guinea-Bissau. BMC Public Health. 2013 Feb 25;13:172. doi: 10.1186/1471-2458-13-172.

  PMID: 23442248 DERIVED

MeSH Terms

Interventions

Vitamin A

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Christine S Benn, MD, PhD

  Bandim Health Project, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark

  PRINCIPAL INVESTIGATOR

• Peter Aaby, Dr.Med.

  Bandim Health Project, Apartado 861, 1004 Bissau Codex, Guinea-Bissau

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 10, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 1, 2011

Record last verified: 2011-01

Locations

GU (1)