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Completed

NCT Number: NCT01782001

Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

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.

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Key information

Conditions

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

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kintampo Health Research Centre

Kintampo, Brong Ahafo, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin A

Dietary Supplement

vitamin A with placebo

vitamin A and zinc

Dietary Supplement

combination of vitamin A and zinc supplements

Primary outcomes

  1. incidence of clinical malaria attacks

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kintampo Health Research Centre, Ghana

Other

Collaborators

  • International Atomic Energy Agency
  • University of Wisconsin, Madison

Registry information

Official study title

Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 1, 2013
Registry last updated
Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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