Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782001
• Other study ID #: AMANI
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2013
• Last updated: January 30, 2013
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2013
• Source: Kintampo Health Research Centre, Ghana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana : Food and Drugs Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malnutrition

Intervention

Dietary Supplement:
• vitamin A
vitamin A with placebo
• vitamin A and zinc
combination of vitamin A and zinc supplements

Locations

Country	Name	City	State
Ghana	Kintampo Health Research Centre	Kintampo	Brong Ahafo

Sponsors (3)

Lead Sponsor	Collaborator
Kintampo Health Research Centre, Ghana	International Atomic Energy Agency, University of Wisconsin, Madison

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of clinical malaria attacks		6 months	No
Secondary	changes in weight and height/length	Enrollment and end of supplementation	baseline and 6 months	No
Secondary	changes in vitamin A and zinc nutritional status within and between the groups	enrollment and end of supplementation	baseline and 6 months	No
Secondary	change in prevalence of anemia	enrollment and end of supplementation	baseline and 6 months	No
Secondary	the incidence of diarrhea and pneumonia	1 time/week, enrollment to end, total:24	1 time per week up to 6 months	No