The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children

NCT ID: NCT02878265

Last Updated: 2016-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

547 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

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The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity

Detailed Description

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A total of 542 children aged between 6-59 months received either: (i) VA (control) or (ii) VA \& Z (VAZ) or (iii) VA, Z \& MV (VAZM). VA was delivered as a single dose while MV and Z were delivered daily. Malaria cases were managed by community health workers, who used rapid diagnostic test to confirm infection prior to treatment.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vitamin A

A single dose of 20,000IU Vitamin A for the whole study period

Group Type PLACEBO_COMPARATOR

Vitamin A

Intervention Type DIETARY_SUPPLEMENT

Vitamin A supplements

Vitamin A and zinc

A single dose of 20,000IU Vitamin A and 10mg of elemental zinc each day for 5 months

Group Type ACTIVE_COMPARATOR

Vitamin A and ZInc

Intervention Type DIETARY_SUPPLEMENT

Combination of vitamin A and zinc supplements

Vitamin A , Zinc and Multivitamin

A single dose of 20,000IU Vitamin A , 10mg of elemental zinc each day and 0.5ml/kg multivitamin syrup for 5 months

Group Type ACTIVE_COMPARATOR

Vitamin A , Zinc and Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Combination of vitamin A, zinc and multivitamins

Interventions

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Vitamin A

Vitamin A supplements

Intervention Type DIETARY_SUPPLEMENT

Vitamin A and ZInc

Combination of vitamin A and zinc supplements

Intervention Type DIETARY_SUPPLEMENT

Vitamin A , Zinc and Multivitamin

Combination of vitamin A, zinc and multivitamins

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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VA VAZ VAZM

Eligibility Criteria

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Inclusion Criteria

* under 5years
* will stay in the community for 10years

Exclusion Criteria

* chronic diseases
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kwame Nkrumah University of Science and Technology

OTHER

Sponsor Role collaborator

University of Ghana

OTHER

Sponsor Role lead

Responsible Party

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Wilhelmina Annie Mensah

Ms

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia k Brown, PhD

Role: STUDY_CHAIR

Kwame Nkrumah Univeristy of Science and Technolgy

Wilhelmina A Mensah, Mphil

Role: PRINCIPAL_INVESTIGATOR

University of Ghana

Locations

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Amoako

Accra, Accra, Ghana

Site Status

Countries

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Ghana

References

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Veenemans J, Milligan P, Prentice AM, Schouten LR, Inja N, van der Heijden AC, de Boer LC, Jansen EJ, Koopmans AE, Enthoven WT, Kraaijenhagen RJ, Demir AY, Uges DR, Mbugi EV, Savelkoul HF, Verhoef H. Effect of supplementation with zinc and other micronutrients on malaria in Tanzanian children: a randomised trial. PLoS Med. 2011 Nov;8(11):e1001125. doi: 10.1371/journal.pmed.1001125. Epub 2011 Nov 22.

Reference Type BACKGROUND
PMID: 22131908 (View on PubMed)

Zeba AN, Sorgho H, Rouamba N, Zongo I, Rouamba J, Guiguemde RT, Hamer DH, Mokhtar N, Ouedraogo JB. Major reduction of malaria morbidity with combined vitamin A and zinc supplementation in young children in Burkina Faso: a randomized double blind trial. Nutr J. 2008 Jan 31;7:7. doi: 10.1186/1475-2891-7-7.

Reference Type RESULT
PMID: 18237394 (View on PubMed)

Owusu-Agyei S, Newton S, Mahama E, Febir LG, Ali M, Adjei K, Tchum K, Alhassan L, Moleah T, Tanumihardjo SA. Impact of vitamin A with zinc supplementation on malaria morbidity in Ghana. Nutr J. 2013 Sep 23;12:131. doi: 10.1186/1475-2891-12-131.

Reference Type RESULT
PMID: 24330422 (View on PubMed)

Imdad A, Herzer K, Mayo-Wilson E, Yakoob MY, Bhutta ZA. Vitamin A supplementation for preventing morbidity and mortality in children from 6 months to 5 years of age. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008524. doi: 10.1002/14651858.CD008524.pub2.

Reference Type RESULT
PMID: 21154399 (View on PubMed)

Other Identifiers

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VAZ20016

Identifier Type: -

Identifier Source: org_study_id

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