NCT02878265

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

August 16, 2016

Last Update Submit

August 19, 2016

Conditions

Malaria

Keywords

malariavitamin AZincMultivitamin

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinical malaria attacks

    While taking the supplement, malaria incidence will be measured

    Baseline and every month up to six months

Secondary Outcomes (1)

  • Incidence of diarrhea attacks

    Every month up to six months

Study Arms (3)

Vitamin A

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin A

Vitamin A and zinc

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin A and ZInc

Vitamin A , Zinc and Multivitamin

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin A , Zinc and Multivitamin

Interventions

Vitamin ADIETARY_SUPPLEMENT

Vitamin A supplements

Also known as: VA
Vitamin A
Vitamin A and ZIncDIETARY_SUPPLEMENT

Combination of vitamin A and zinc supplements

Also known as: VAZ
Vitamin A and zinc
Vitamin A , Zinc and MultivitaminDIETARY_SUPPLEMENT

Combination of vitamin A, zinc and multivitamins

Also known as: VAZM
Vitamin A , Zinc and Multivitamin

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amoako

Accra, Accra, 233, Ghana

Location

Related Publications (4)

  • 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.

    PMID: 22131908BACKGROUND

  • 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.

    PMID: 18237394RESULT

  • 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.

    PMID: 24330422RESULT

  • 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.

    PMID: 21154399RESULT

MeSH Terms

Conditions

Malaria

Interventions

Vitamin AZincGeritol

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Patricia k Brown, PhD

    Kwame Nkrumah Univeristy of Science and Technolgy

    STUDY CHAIR

  • Wilhelmina A Mensah, Mphil

    University of Ghana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 25, 2016

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

To meet the participants and explain the results of their data to them

Locations

GH(1)