Impact of the WHO Recommended Vitamin A Supplementation a... | NCT00514891

Studies
Impact of the WHO Recommended Vitamin A Supplementation at Immunisation Contacts

NCT00514891

Sponsor

Bandim Health Project

Status

Terminated

Last Update Posted

Mar 1, 2011Estimated

Enrollment

9,500Estimated

Phase

Phase 4

Conditions

Mortality
Morbidity

Interventions

Vitamin A

Countries

Guinea-Bissau

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Reccomended by DSMB after review of planned interim analyses.

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Jun 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Aug 8, 2007

First Submission Date that Met QC Criteria

Aug 9, 2007

First Posted Date

Aug 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2011

Last Update Posted Date

Mar 1, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Bandim Health ProjectOTHER

Collaborators

Name	Class
Ministry of Public Health, Guinea-Bissau	OTHER_GOV
University of Aarhus	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Vitamin A supplementation	Biological: Vitamin A
2	Placebo Comparator	Placebo	Biological: Vitamin A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin A	Biological	The effect of vitamin A given with different vaccines will be studied	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality, morbidity		1 year

Secondary Outcomes

Measure	Description	Time Frame
Growth, Vitamin A status, Immunology

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

23 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bandim Health Project, Apartado 861		Bissau			Guinea-Bissau

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25136048	Derived	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.
23680441	Derived

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839