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Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

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ClinicalTrials.gov Identifier: NCT01782001
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : February 1, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Malaria Malnutrition Dietary Supplement: vitamin A Dietary Supplement: vitamin A and zinc Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana
Study Start Date : March 2009
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Vitamin A
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. incidence of clinical malaria attacks [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. changes in weight and height/length [ Time Frame: baseline and 6 months ]
    Enrollment and end of supplementation

  2. changes in vitamin A and zinc nutritional status within and between the groups [ Time Frame: baseline and 6 months ]
    enrollment and end of supplementation

  3. change in prevalence of anemia [ Time Frame: baseline and 6 months ]
    enrollment and end of supplementation

  4. the incidence of diarrhea and pneumonia [ Time Frame: 1 time per week up to 6 months ]
    1 time/week, enrollment to end, total:24


Eligibility Criteria

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kintampo Health Research Centre, Ghana
ClinicalTrials.gov Identifier: NCT01782001     History of Changes
Other Study ID Numbers: AMANI
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

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
Vitamins
Vitamin A
Zinc
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents