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Trial NCT00514891

Resource URI: http://static.linkedct.org/resource/trials/NCT00514891
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/12349>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/20576>
linkedct:brief_title Evaluation of the Impact of the WHO Recommended Vitamin A Supplementation at First Immunisation Contact After 6 Months of Age
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5171>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8658>
linkedct:condition <http://static.linkedct.org/resource/condition/8261>
linkedct:condition <http://static.linkedct.org/resource/condition/8267>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_maximum_age 23 Months
linkedct:eligibility_minimum_age 6 Months
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date August 8, 2007
linkedct:has_dmc Yes
linkedct:id NCT00514891
linkedct:intervention <http://static.linkedct.org/resource/intervention/53507>
rdfs:label Trial NCT00514891
linkedct:lastchanged_date November 6, 2008
linkedct:lead_sponsor_agency Bandim Health Project
linkedct:location <http://static.linkedct.org/resource/location/68639>
linkedct:nct_id NCT00514891
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct: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
linkedct:org_study_id CVK-2006-7041-99
linkedct:overall_contact_email a.fisker@bandim.org
linkedct:overall_contact_last_name Ane B Fisker, MD
linkedct:overall_contact_phone +245 201489
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/46476>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/9477>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1249>
linkedct:oversight <http://static.linkedct.org/resource/oversight/678>
foaf:page <http://clinicaltrials.gov/show/NCT00514891>
linkedct:phase Phase 4
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/13258>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/49696>
linkedct:source Bandim Health Project
linkedct:start_date August 2007
linkedct:study_design Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date November 2008