Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

Kintampo Health Research Centre, Ghana

Status and phase: Completed; Phase 3

Conditions: Malnutrition; Malaria

Treatments: Dietary Supplement: vitamin A and zinc; Dietary Supplement: vitamin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01782001

AMANI

Details and patient eligibility

About

The purpose of this study was to determine whether young children receiving Vitamin A and Zinc supplements will have a lower incidence of symptomatic malaria than similar children receiving vitamin A supplements alone.

Full description

The aim of our study was to determine the impact of the combination of vitamin A and zinc supplements on malaria morbidity in young children. The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria. The specific objectives were to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on changes in anthropometric measurements specifically weight and length/height and to assess the effect of the study interventions on the incidence of anemia, diarrhea and pneumonia. It also assessed the tolerability of the supplements and determined the change in zinc status by measuring plasma zinc concentration using atomic absorption spectrometry before and at the end of the intervention. The study also determined the change in vitamin A status as assessed by the modified relative dose response (MRDR) test during and at the end of the intervention.

Enrollment: 200 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 6 - 24 months
• Child's guardian is willing to provide informed consent
• Child's family plans to remain resident in the study areas during the study period

Exclusion criteria

• Clinical evidence of vitamin A deficiency
• Severe acute malnutrition
• Severe illness
• Child aged <6 months or >24 months
• Receipt of vitamin A supplement within the last three months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Vitamin A and zinc

Experimental group

Description:

combination of vitamin A and zinc supplements

Treatment:

Dietary Supplement: vitamin A and zinc

Vitamin A and placebo

Active Comparator group

Description:

vitamin A with placebo

Treatment:

Dietary Supplement: vitamin A