Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants

NCT03181178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1204

Last updated 2018-03-01

No results posted yet for this study

Summary

Prevention of malnutrition in infants and children requires access and intake of nutritious food starting at birth with exclusive breastfeeding for the first 6 months of life, breastfeeding in combination with complementary foods from 6-24 months of age, access to clean drinking water and sanitation, access to preventive and curative health care (including prenatal).

In Ghana, the Demographic and Health Survey of 2014 reports rates of stunting, wasting and underweight in children aged 0-59 months are 28%, 14% and 9% respectively. Furthermore, height for age starts dropping from age 4-6 months with children aged 6-23 months being more likely to be stunted (40%) than those below 6 months (4%). Infant and young child feeding data show that for breast-fed children ranging from 6 months through 35 months of age, cereals are predominantly the first foods introduced in the diet (6-8 months of age). As the child grows older, consumption of fruits rich in Vitamin A, other fruits and vegetables and meat, fish, poultry and eggs are reported by the mothers. The Demographic and Health Survey (DHS) found that the proportion of breast fed children aged 6-23 months who received a recommended variety of foods the minimum number of times per day increases with child's age from 28% in children 6-8 months to 50% in children aged 18-23 months.

The study objective is to examine the effect of providing a macro- and micro-nutrient fortified complementary food supplement (KokoPlusTM) on growth and nutritional status of Ghanaian infants.

Conditions

  • Growth Disorders
  • Infant Malnutrition
  • Micronutrient Deficiency
  • Protein Malnutrition
  • Morbidity;Infant

Interventions

DIETARY_SUPPLEMENT

Macro-micronutrient complementary food supplement

This intervention provided a 15 g complementary food supplement called KokoPlus with nutrition education

DIETARY_SUPPLEMENT

A micronutrient powder

This intervention provided a 1 g micronutrient powder with nutrition education

BEHAVIORAL

Nutrition education

This intervention provided nutrition education sessions

Sponsors & Collaborators

  • University of Ghana

    collaborator OTHER
  • University of Cape Coast

    collaborator OTHER
  • Ajinomoto USA, INC.

    collaborator INDUSTRY
  • Ghana Health Services

    collaborator OTHER_GOV
  • Nevin Scrimshaw International Nutrition Foundation

    lead OTHER

Principal Investigators

  • Shibani Ghosh, PhD · Nevin Scrimshaw International Nutrition Foundation

  • Gloria Otoo, PhD · University of Ghana

  • Kwaku Tano-Debrah, PhD · University of Ghana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-02-28
Completion
2015-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03181178 on ClinicalTrials.gov