DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity

Information source: Kintampo Health Research Centre, Ghana
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria; Malnutrition

Intervention: vitamin A (Dietary Supplement); vitamin A and zinc (Dietary Supplement)

Phase: Phase 3

Status: Completed

Sponsored by: Kintampo Health Research Centre, Ghana

Official(s) and/or principal investigator(s):
Seth Owusu-Agyei, PhD, Principal Investigator, Affiliation: Kintampo Health Research Centre, Ghana

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.

Clinical Details

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

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

Primary outcome: incidence of clinical malaria attacks

Secondary outcome:

changes in weight and height/length

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

change in prevalence of anemia

the incidence of diarrhea and pneumonia

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

Minimum age: 6 Months. Maximum age: 24 Months. Gender(s): Both.

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

Locations and Contacts

Kintampo Health Research Centre, Kintampo, Brong Ahafo, Ghana
Additional Information

Starting date: March 2009
Last updated: January 30, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017