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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 3
Locations
Ghana
Study Type
Interventional
Intervention
Vitamin A
Vitamin A and ZInc
Vitamin A , Zinc and Multivitamin
Sponsored by
University of Ghana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring malaria, vitamin A, Zinc, Multivitamin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic diseases

Sites / Locations

  • Amoako

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Vitamin A

Vitamin A and zinc

Vitamin A , Zinc and Multivitamin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Incidence of clinical malaria attacks
While taking the supplement, malaria incidence will be measured

Secondary Outcome Measures

Incidence of diarrhea attacks
While taking the supplement, diarrhea incidence will be measured

Full Information

First Posted
August 16, 2016
Last Updated
August 19, 2016
Sponsor
University of Ghana
Collaborators
Kwame Nkrumah University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02878265
Brief Title
The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children
Official Title
The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ghana
Collaborators
Kwame Nkrumah University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria, vitamin A, Zinc, Multivitamin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin A
Arm Type
Placebo Comparator
Arm Description
A single dose of 20,000IU Vitamin A for the whole study period
Arm Title
Vitamin A and zinc
Arm Type
Active Comparator
Arm Description
A single dose of 20,000IU Vitamin A and 10mg of elemental zinc each day for 5 months
Arm Title
Vitamin A , Zinc and Multivitamin
Arm Type
Active Comparator
Arm Description
A single dose of 20,000IU Vitamin A , 10mg of elemental zinc each day and 0.5ml/kg multivitamin syrup for 5 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A
Other Intervention Name(s)
VA
Intervention Description
Vitamin A supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A and ZInc
Other Intervention Name(s)
VAZ
Intervention Description
Combination of vitamin A and zinc supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A , Zinc and Multivitamin
Other Intervention Name(s)
VAZM
Intervention Description
Combination of vitamin A, zinc and multivitamins
Primary Outcome Measure Information:
Title
Incidence of clinical malaria attacks
Description
While taking the supplement, malaria incidence will be measured
Time Frame
Baseline and every month up to six months
Secondary Outcome Measure Information:
Title
Incidence of diarrhea attacks
Description
While taking the supplement, diarrhea incidence will be measured
Time Frame
Every month up to six months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: under 5years will stay in the community for 10years Exclusion Criteria: chronic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia k Brown, PhD
Organizational Affiliation
Kwame Nkrumah Univeristy of Science and Technolgy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wilhelmina A Mensah, Mphil
Organizational Affiliation
University of Ghana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amoako
City
Accra
ZIP/Postal Code
233
Country
Ghana

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
To meet the participants and explain the results of their data to them
Citations:
PubMed Identifier
22131908
Citation
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.
Results Reference
background
PubMed Identifier
18237394
Citation
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.
Results Reference
result
PubMed Identifier
24330422
Citation
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.
Results Reference
result
PubMed Identifier
21154399
Citation
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.
Results Reference
result

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

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