Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

NCT01782001 | Completed Phase 3 DMC

• 1 other identifier: AMANI
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria; Malnutrition

Keywords

Vitamin A; Zinc; Malaria; Morbidity; MRDR

Outcome Measures

Primary Outcomes (1)

• incidence of clinical malaria attacks

  6 months

Secondary Outcomes (4)

• changes in weight and height/length

  baseline and 6 months

• changes in vitamin A and zinc nutritional status within and between the groups

  baseline and 6 months

• change in prevalence of anemia

  baseline and 6 months

• the incidence of diarrhea and pneumonia

  1 time per week up to 6 months

Study Arms (2)

Vitamin A and zinc

EXPERIMENTAL

combination of vitamin A and zinc supplements

Dietary Supplement: vitamin A and zinc

Vitamin A and placebo

ACTIVE COMPARATOR

vitamin A with placebo

Dietary Supplement: vitamin A

Interventions

vitamin A DIETARY_SUPPLEMENT

vitamin A with placebo

Vitamin A and placebo

vitamin A and zinc DIETARY_SUPPLEMENT

combination of vitamin A and zinc supplements

Vitamin A and zinc

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kintampo Health Research Centre, Ghana: lead
• International Atomic Energy Agency: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Kintampo Health Research Centre

Kintampo, Brong Ahafo, Ghana

Location

MeSH Terms

Conditions

Malaria; Malnutrition

Interventions

Vitamin A; Zinc

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Seth Owusu-Agyei, PhD

  Kintampo Health Research Centre, Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: February 1, 2013
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

GH (1)