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

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ClinicalTrials.gov Identifier: NCT03181178
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborators:
University of Ghana
University of Cape Coast
Ajinomoto USA, INC.
Ghana Health Services
Information provided by (Responsible Party):
Shibani Ghosh, Nevin Scrimshaw International Nutrition Foundation

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.


Condition or disease Intervention/treatment Phase
Growth Disorders Infant Malnutrition Micronutrient Deficiency Protein Malnutrition Morbidity;Infant Dietary Supplement: Macro-micronutrient complementary food supplement Dietary Supplement: A micronutrient powder Behavioral: Nutrition education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study has three intervention arms and one cross sectional growth monitoring follow up group.
Masking: Single (Participant)
Masking Description: Single blind cluster randomized trial - all participants in a community received the same treatment.
Primary Purpose: Prevention
Official Title: Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants (6 to 18 Months)
Actual Study Start Date : February 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: KokoPlus and Nutrition Education
Macro-micronutrient complementary food supplement and Nutrition Education
Dietary Supplement: Macro-micronutrient complementary food supplement
This intervention provided a 15 g complementary food supplement called KokoPlus with nutrition education

Behavioral: Nutrition education
This intervention provided nutrition education sessions

Active Comparator: Micronutrient and Nutrition Education
A micronutrient powder and 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

Active Comparator: Nutrition Education Only
Nutrition Education
Behavioral: Nutrition education
This intervention provided nutrition education sessions

No Intervention: Growth Monitoring Only
Growth monitoring



Primary Outcome Measures :
  1. Change in monthly length for age Z-score (monthly LAZ) [ Time Frame: Measured on a monthly basis until 18 months of age ]
    Change in length for age Z-score from 6 months to 18 months of age.


Secondary Outcome Measures :
  1. Change in Serum Hemoglobin [ Time Frame: Baseline (6 months), Midline (12 months of age), Endline (18 months of age) ]
    Change in serum hemoglobin from baseline to endline (6 months to 18 months)

  2. Change in Serum retinol binding protein [ Time Frame: Baseline (6 months), Midline (12 months of age), Endline (18 months of age) ]
    Change in serum retinol binding protein from baseline to endline (6 months to 18 months)

  3. Change in serum transferrin receptors [ Time Frame: Baseline (6 months), Midline (12 months of age), Endline (18 months of age) ]
    Change from baseline to endline (6 months to 18 months)

  4. Change in serum ferritin [ Time Frame: Baseline (6 months), Midline (12 months of age), Endline (18 months of age) ]
    Change from baseline to endline (6 months to 18 months)

  5. Change in serum zinc [ Time Frame: Baseline (6 months), Midline (12 months of age), Endline (18 months of age) ]
    Change from baseline to endline (6 months to 18 months)

  6. Change in Weight for age Z-score [ Time Frame: Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) ]
    This is the change in weight for age Z-score from 6 months to 18 months of age

  7. Change in Weight for height Z-score [ Time Frame: Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) ]
    This is the change in weight for length Z-score from 6 months to 18 months of age

  8. Prevalence of diarrhea [ Time Frame: Measured at baseline and then in a weekly surveillance for the duration of the intervention (12 months or 52 weeks) ]
    Prevalence of diarrhea over a 12 month period (duration of intervention)

  9. Prevalence of upper respiratory infections [ Time Frame: Measured at baseline and then in a weekly surveillance for the duration of the intervention (12 months or 52 weeks) ]
    Prevalence of respiratory infections over a 12 month period (duration of the intervention)

  10. Change in serum C-reactive protein [ Time Frame: Baseline (6 months), Midline (12 months of age), Endline (18 months of age) ]
    Change from baseline to endline (6 months to 18 months)

  11. Change in serum alpha glycoprotein [ Time Frame: Baseline (6 months), Midline (12 months of age), Endline (18 months of age) ]
    Change from baseline to endline (6 months to 18 months)

  12. Change in Head Circumference for age [ Time Frame: Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) ]
    This is the change in head circumference for age from 6 months to 18 months of

  13. Change in MUAC (Mid Upper Arm Circumference) [ Time Frame: Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) ]
    This is the change in MUAC for age from 6 months to 18 months of age

  14. Change in Plasma Amino Acid levels [ Time Frame: Baseline (6 months), Midline (12 months of age), Endline (18 months of age) ]
    This is the change in individual plasma amino acids from 6 months to 18 months



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severely anemic (<7 g/dl) (to be referred to Community Health Post (CHP) for routine care on anemia as recommended by Ghana Health Service)
  2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181178


Sponsors and Collaborators
Nevin Scrimshaw International Nutrition Foundation
University of Ghana
University of Cape Coast
Ajinomoto USA, INC.
Ghana Health Services
Investigators
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Principal Investigator: 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
Publications:
Pan American Health Organization. Guiding Principles for Complementary Feeding of the Breast Fed Child p37, 2003
Ghana Statistical Service, Ghana Health Service, ICF Macro Ghana Demographic and Health Survey 2008, Accra, Ghana, p 512, 2009

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Responsible Party: Shibani Ghosh, Senior Scientist, Nevin Scrimshaw International Nutrition Foundation
ClinicalTrials.gov Identifier: NCT03181178    
Other Study ID Numbers: Ghana Trial
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shibani Ghosh, Nevin Scrimshaw International Nutrition Foundation:
Complementary food supplement
Protein quality and linear growth
Intervention targeting complementary foods and growth
Additional relevant MeSH terms:
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Malnutrition
Infant Nutrition Disorders
Kwashiorkor
Growth Disorders
Nutrition Disorders
Pathologic Processes
Severe Acute Malnutrition
Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs