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

NCT03181178 | Completed DMC

• 1 other identifier: Ghana Trial
• Study Type: interventional
• Target: 1,204
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Complementary food supplement; Protein quality and linear growth; Intervention targeting complementary foods and growth

Outcome Measures

Primary Outcomes (1)

• Change in monthly length for age Z-score (monthly LAZ)

  Change in length for age Z-score from 6 months to 18 months of age.

  Measured on a monthly basis until 18 months of age

Secondary Outcomes (14)

• Change in Serum Hemoglobin

  Baseline (6 months), Midline (12 months of age), Endline (18 months of age)

• Change in Serum retinol binding protein

  Baseline (6 months), Midline (12 months of age), Endline (18 months of age)

• Change in serum transferrin receptors

  Baseline (6 months), Midline (12 months of age), Endline (18 months of age)

• Change in serum ferritin

  Baseline (6 months), Midline (12 months of age), Endline (18 months of age)

• Change in serum zinc

  Baseline (6 months), Midline (12 months of age), Endline (18 months of age)

Study Arms (4)

KokoPlus and Nutrition Education

ACTIVE COMPARATOR

Macro-micronutrient complementary food supplement and Nutrition Education

Dietary Supplement: Macro-micronutrient complementary food supplement; Behavioral: Nutrition education

Micronutrient and Nutrition Education

ACTIVE COMPARATOR

A micronutrient powder and Nutrition Education

Dietary Supplement: A micronutrient powder; Behavioral: Nutrition education

Nutrition Education Only

ACTIVE COMPARATOR

Nutrition Education

Behavioral: Nutrition education

Growth Monitoring Only

NO INTERVENTION

Growth monitoring

Interventions

Macro-micronutrient complementary food supplement DIETARY_SUPPLEMENT

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

KokoPlus and Nutrition Education

A micronutrient powder DIETARY_SUPPLEMENT

This intervention provided a 1 g micronutrient powder with nutrition education

Micronutrient and Nutrition Education

Nutrition education BEHAVIORAL

This intervention provided nutrition education sessions

KokoPlus and Nutrition Education; Micronutrient and Nutrition Education; Nutrition Education Only

Eligibility Criteria

• Age: 6 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Non pre-term
• Singleton birth
• Exclusively or predominantly breast fed up to time of recruitment
• Parents planning to live in community for a period of 12 months and willing to participate in the trial for the entire period
• Receive informed consent from both parents and/or caregivers or from mother alone if single

You may not qualify if:

• Severely anemic (\<7 g/dl) (to be referred to Community Health Post (CHP) for routine care on anemia as recommended by Ghana Health Service)
• Severely malnourished (MUAC \<110 mm) (to be referred to CHP with Community-based Management of Acute Malnutrition (CMAM) protocol) and/or use of CMAM protocol or below -2 standard deviations (SD) weight for age Z score

Sponsors & Collaborators

• Nevin Scrimshaw International Nutrition Foundation: lead
• University of Ghana: collaborator
• University of Cape Coast: collaborator
• Ajinomoto USA, INC.: collaborator
• Ghana Health Services: collaborator

Related Publications (4)

• de Pee S, Bloem MW. Current and potential role of specially formulated foods and food supplements for preventing malnutrition among 6- to 23-month-old children and for treating moderate malnutrition among 6- to 59-month-old children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S434-63. doi: 10.1177/15648265090303S305.

  PMID: 19998866 BACKGROUND

• Pan American Health Organization. Guiding Principles for Complementary Feeding of the Breast Fed Child p37, 2003

  BACKGROUND

• Ghana Statistical Service, Ghana Health Service, ICF Macro Ghana Demographic and Health Survey 2008, Accra, Ghana, p 512, 2009

  BACKGROUND

• Furuta C, Sato W, Murakami H, Suri DJ, Otoo GE, Tano-Debrah K, Ghosh SA. Changes of Plasma Amino Acid Profiles in Infants With a Nutrient-Fortified Complementary Food Supplement: Evidence From a 12-Month Single-Blind Cluster-Randomized Controlled Trial. Front Nutr. 2021 Sep 30;8:606002. doi: 10.3389/fnut.2021.606002. eCollection 2021.

  PMID: 34660654 DERIVED

MeSH Terms

Conditions

Growth Disorders; Infant Nutrition Disorders; Kwashiorkor

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Severe Acute Malnutrition; Malnutrition

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Shibani Ghosh, PhD

  Nevin Scrimshaw International Nutrition Foundation

  PRINCIPAL INVESTIGATOR

• Gloria Otoo, PhD

  University of Ghana

  PRINCIPAL INVESTIGATOR

• Kwaku Tano-Debrah, PhD

  University of Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind cluster randomized trial - all participants in a community received the same treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: The study has three intervention arms and one cross sectional growth monitoring follow up group.

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 8, 2017
• Study Start: February 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share