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

University of Ghana

Status and phase: Completed; Phase 3

Conditions: Malaria

Treatments: Dietary Supplement: Vitamin A , Zinc and Multivitamin; Dietary Supplement: Vitamin A and ZInc; Dietary Supplement: Vitamin A

Study type: Interventional

Funder types: Other

Identifiers

NCT02878265

VAZ20016

Details and patient eligibility

About

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

Full 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.

Enrollment: 547 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• chronic diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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547 participants in 3 patient groups, including a placebo group

Vitamin A

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin A

Vitamin A and zinc

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin A and ZInc

Vitamin A , Zinc and Multivitamin

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin A , Zinc and Multivitamin