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

U

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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