Impact of the WHO Recommended Vitamin A Supplementation at Immunisation Contacts

This study has been terminated.
(Reccomended by DSMB after review of planned interim analyses.)
Sponsor:
Collaborators:
Ministry of Health, Guinea-Bissau
University of Aarhus
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00514891
First received: August 8, 2007
Last updated: February 26, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Mortality
Morbidity
Biological: Vitamin A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Impact on Mortality and Morbidity of the WHO Recommended Vitamin A Supplementation at First Immunisation Contact After 6 Months of Age

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality, morbidity [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Growth, Vitamin A status, Immunology

Estimated Enrollment: 9500
Study Start Date: August 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Vitamin A supplementation
Biological: Vitamin A
The effect of vitamin A given with different vaccines will be studied
Placebo Comparator: 2
Placebo
Biological: Vitamin A
The effect of vitamin A given with different vaccines will be studied

  Eligibility

Ages Eligible for Study:   6 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Normally applied contraindications for receiving vaccinations, including high fever.
  • VAS within last month.
  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: NCT00514891

Locations
Guinea-Bissau
Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Ministry of Health, Guinea-Bissau
University of Aarhus
Investigators
Principal Investigator: Christine S Benn, MD, PhD Bandim Health Project, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark
Study Director: Peter Aaby, Dr.Med. Bandim Health Project, Apartado 861, 1004 Bissau Codex, Guinea-Bissau
  More Information

No publications provided by Bandim Health Project

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ane Fisker, Bandim Health Project
ClinicalTrials.gov Identifier: NCT00514891     History of Changes
Other Study ID Numbers: CVK-2006-7041-99
Study First Received: August 8, 2007
Last Updated: February 26, 2011
Health Authority: Guinea-Bissau: Ministry of Health
Denmark: Ethics Committee

Additional relevant MeSH terms:
Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014