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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

Tracking Information
First Submitted Date  ICMJE June 5, 2017
First Posted Date  ICMJE June 8, 2017
Last Update Posted Date March 1, 2018
Actual Study Start Date  ICMJE February 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants
Official Title  ICMJE Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants (6 to 18 Months)
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.

Detailed Description

The current study is a cluster randomized single blind intervention design study with three study arms that aimed to examine the effect of providing a macro- and micro-nutrient fortified complementary food supplement (KokoPlus) for a period of 12 months (starting at 6 months of age) on growth and nutritional status of Ghanaian infants at 18 months of age. KokoPlus was formulated using linear programming methodology based on formative and market analysis research findings.

The subjects in this cluster-randomized trial are from communities in three districts of the Central region in Ghana with high rates of moderate and severe acute malnutrition. A total of 38 communities will be randomly assigned to one of three groups using block randomization and another 11 (randomly selected) will be followed cross sectionally as part of a fourth/non intervention group (growth monitoring).

The total sample size is 1204. Sample size calculations were based on two outcome measures: expected reduction in diarrheal morbidity and growth (improvements in height-for-age). Sample size estimates for detecting a 0.5 cm change in height in children provided a caloric and non caloric micronutrient supplement using a design effect of 2, power of 0.80, alpha of 0.05 and assuming an attrition rate of 15%, the required sample size per group was 301.

Mother-infant pairs will be recruited between infant age of 0 to 3 months to participate in monthly nutrition educations sessions and to encourage the women to continue exclusive breast feeding across all three groups. At 6 months of age, infants in each of the three groups were enrolled into the intervention study (upon receipt of informed consent). Data collection involves baseline, midline and endline measurements in the infants at 6, 12 and 18 months of age. In addition, participating mother-infant pairs will be visited weekly for delivery of the supplements and for morbidity monitoring and monthly for the measurement of anthropometry. Anthropometric measurements include: length (Infant/Child Shorr Height Board; Weigh and Measure, LLC ), weight (Seca 874 digital scale ), mid-upper arm circumference (MUAC) (Child MUAC Tape; Weigh and Measure, LLC), subscapular and triceps skinfolds (Holtain skinfold caliper ),head and chest circumference.

Data collection at baseline, midline and endline included one venous sample (3ml) from the infant, HemoCue (Model 301) measurement to assess severe anemia (7 <g/dl) with appropriate referrals as mentioned earlier. Ethylenediaminetetracetic acid (EDTA) Vacutainers (BD ; catalog number 368841) for whole blood and plasma analyses and Trace Element Serum Separator Tube Vacutainers (BD; catalog number 368380) for serum analyses will be used for the sample collection with butterfly needles (21 or 23 gauge). Samples will be immediately placed in a super cooler tube rack and transported back to the lab within five hours where they were processed immediately. Questionnaires will be administered to assess socio-economic status, infant and young child feeding practices, morbidity (past week), household food security along with a 24 hour diet recall. Data was uploaded daily through cellular network, stored on Formhub and then Ona organization servers.

The primary outcome of the study is the change in length for age Z-score from 6 to 18 months of age in infants in the KokoPlus group versus Micronutrient powder group and the Nutrition Education group. Data calculations included estimating anthropometric indices using the WHO (World Health Organization) 2006 growth reference charts using the WHO macro in STATA (18), computing the USAID Food and Nutrition Technical Assistance (FANTA) household insecurity access scores (HFIAS) (19) maternal body mass index (BMI), dietary diversity scores (20), and re-coding variables as required to binary and accounting for missing. Infant anthropometric indices calculated include length for age (LAZ) Z- score, weight for age Z-score (WAZ) and weight for length (WLZ score).

All analyses are intent to treat. Descriptive statistics (means, medians, standard deviations and standard errors) were computed. To verify the randomization assumption, any differences in mean values at baseline across three groups were tested using linear mixed effects regression analyses accounting for clustering. The effect of the supplement (KokoPlus, Micronutrients and Nutrition Education group) on different dependent variables across the intervention period will be tested using mixed effects regression analyses accounting for clustering and repeated measures. The dependent variables tested included change in LAZ between baseline and endline (primary outcome), change in LAZ on a monthly basis (primary outcome 2), change in WAZ, WLZ, serum hemoglobin (unadjusted and adjusted for inflammation), serum ferritin (unadjusted and adjusted for inflammation), serum zinc, serum cortisol, serum insulin growth factor-1 (IGF-1), serum retinol binding protein, C-reactive protein and alpha glycoprotein, prevalence of acute and chronic infection.

A cross-sectional assessment (anthropometry) will be conducted at baseline, midline and endline in 301 infants that are randomly selected from another set of communities (to be identified based on the same community selection criteria). These infants will not be followed longitudinally and the only measurements to be collected include weights and heights. Informed consent procedures will be similar to the three intervention arms. This group is a reference group only and cannot be included in any comparative analysis.

Monitoring of groups that receive a supplement will happen weekly. Compliance will be defined based on the number of supplement packets that are consumed per week. To assure that the mothers are compliant in using the supplement, they will be asked to return the empty supplement packages at the end of the week. Optimal compliance will be defined as consumption of at least 50% of the weekly samples. Supplements will be provided in plastic or paper bags with a clearly labelled household ID (identity number). Compliance and dose response to compliance will be reviewed in existing studies to determine minimum compliance required.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Growth Disorders
  • Infant Malnutrition
  • Micronutrient Deficiency
  • Protein Malnutrition
  • Morbidity;Infant
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: KokoPlus and Nutrition Education
    Macro-micronutrient complementary food supplement and Nutrition Education
    Interventions:
    • Dietary Supplement: Macro-micronutrient complementary food supplement
    • Behavioral: Nutrition education
  • Active Comparator: Micronutrient and Nutrition Education
    A micronutrient powder and Nutrition Education
    Interventions:
    • Dietary Supplement: A micronutrient powder
    • Behavioral: Nutrition education
  • Active Comparator: Nutrition Education Only
    Nutrition Education
    Intervention: Behavioral: Nutrition education
  • No Intervention: Growth Monitoring Only
    Growth monitoring
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2017)
1204
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181178
Other Study ID Numbers  ICMJE Ghana Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data to other researchers
Responsible Party Shibani Ghosh, Nevin Scrimshaw International Nutrition Foundation
Study Sponsor  ICMJE Nevin Scrimshaw International Nutrition Foundation
Collaborators  ICMJE
  • University of Ghana
  • University of Cape Coast
  • Ajinomoto USA, INC.
  • Ghana Health Services
Investigators  ICMJE
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
PRS Account Nevin Scrimshaw International Nutrition Foundation
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP