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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878265
• Other study ID #: VAZ20016
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2016
• Last updated: August 19, 2016
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2016
• Source: University of Ghana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• under 5years

• will stay in the community for 10years

Exclusion Criteria:

• chronic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Dietary Supplement:
• Vitamin A
Vitamin A supplements
• Vitamin A and ZInc
Combination of vitamin A and zinc supplements
• Vitamin A , Zinc and Multivitamin
Combination of vitamin A, zinc and multivitamins

Locations

Country	Name	City	State
Ghana	Amoako	Accra

Sponsors (2)

Lead Sponsor	Collaborator
University of Ghana	Kwame Nkrumah University of Science and Technology

Country where clinical trial is conducted

Ghana, 

References & Publications (4)

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 — View 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. — View 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. — View Citation

Zeba AN, Sorgho H, Rouamba N, Zongo I, Rouamba J, Guiguemdé 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. Nu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinical malaria attacks	While taking the supplement, malaria incidence will be measured	Baseline and every month up to six months	No
Secondary	Incidence of diarrhea attacks	While taking the supplement, diarrhea incidence will be measured	Every month up to six months	No