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Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

This study has been completed.
Sponsor:
Collaborators:
International Atomic Energy Agency
University of Wisconsin, Madison
Information provided by (Responsible Party):
Kintampo Health Research Centre, Ghana
ClinicalTrials.gov Identifier:
NCT01782001
First received: January 27, 2013
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Malaria
Malnutrition
 Dietary Supplement: vitamin A
Dietary Supplement: vitamin A and zinc
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kintampo Health Research Centre, Ghana:

Primary Outcome Measures:
  • incidence of clinical malaria attacks [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in weight and height/length [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Enrollment and end of supplementation

  • changes in vitamin A and zinc nutritional status within and between the groups [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    enrollment and end of supplementation

  • change in prevalence of anemia [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    enrollment and end of supplementation

  • the incidence of diarrhea and pneumonia [ Time Frame: 1 time per week up to 6 months ] [ Designated as safety issue: No ]
    1 time/week, enrollment to end, total:24


Enrollment: 200
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin A and zinc
combination of vitamin A and zinc supplements
 Dietary Supplement: vitamin A and zinc
combination of vitamin A and zinc supplements
Active Comparator: Vitamin A and placebo
vitamin A with placebo
 Dietary Supplement: vitamin A
vitamin A with placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782001

Locations
Ghana
Kintampo Health Research Centre
Kintampo, Brong Ahafo, Ghana
Sponsors and Collaborators
Kintampo Health Research Centre, Ghana
International Atomic Energy Agency
University of Wisconsin, Madison
Investigators
Principal Investigator: Seth Owusu-Agyei, PhD Kintampo Health Research Centre, Ghana
  More Information

No publications provided

Responsible Party: Kintampo Health Research Centre, Ghana
ClinicalTrials.gov Identifier: NCT01782001     History of Changes
Other Study ID Numbers: AMANI
Study First Received: January 27, 2013
Last Updated: January 30, 2013
Health Authority: Ghana : Food and Drugs Board

Keywords provided by Kintampo Health Research Centre, Ghana:
Vitamin A
Zinc
Malaria
Morbidity
MRDR

Additional relevant MeSH terms:
Malaria
Malnutrition
Protozoan Infections
Parasitic Diseases
Nutrition Disorders
Vitamin A
Vitamins
Zinc
Retinol palmitate
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on June 17, 2013