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Homemade Yogurt Supplementation to Prevent Stunting

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ClinicalTrials.gov Identifier: NCT04067284
Recruitment Status : Not yet recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
University of Western Sydney
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Stunting contributes substantially to child mortality and disease burden in low-income countries. In Bangladesh the prevalence of stunting among children <5-years of age is high (36%) reaching 50% in slum areas. The pathogenesis of stunting is multifaceted, yet nutritional inadequacy and repeated infections are established risk factors of stunting.

A three-arm randomized controlled trial in Dhaka's slum area is proposed. The children will be recruited from vaccination clinics. Infants at risk of stunting (-1 SD length-for-age z-score, LAZ) aged around 5 months are eligible for the study. Eligible children will be randomized to receive: 1) nutrition education on dietary diversity; 2) a combination of similar education plus daily supplementation of homemade yogurt; 3) a 'usual care' (control) group. The investigators will recruit 120 children (40 per arm). Intervention will be initiated a month before starting of complementary feeding with an educational session and will last 7 months during which a monthly educational session will be delivered at participant's household. The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding. Feeding behaviors will be self-monitored using a pictorial calendar. Primary outcome (LAZ) and secondary outcomes (fecal bio-markers, WAZ, head circumference, and food diversity scores), will be measured at baseline (6 months), 9 months and 12 months of child age. Supplementation with homemade yogurt is a novel approach with the potential to improve infant gut environment, improve food absorption and thus potentially prevent stunting.


Condition or disease Intervention/treatment Phase
Child Malnutrition Behavioral: Nutrition education Dietary Supplement: Nutrition education+Homemade yogurt supplementation Other: Usual care Not Applicable

Detailed Description:

Hypothesis:

The investigators hypothesize that, continued breastfeeding, adequate complimentary feeding and supplementation with homemade yogurt have the potential to reduce stunting.

Primary objective:

The present study is aimed to assess the impact of low-cost nutritional strategies to prevent childhood malnutrition in Bangladesh.

Specific objectives:

  1. To compare differences in growth pattern (length-for-age z-score, weight-for age z-score, head circumference) of children at risk of stunting age 6-months between infants receiving educational program only, infants receiving education plus homemade yogurt supplementation and those receiving the "usual-care" (control).
  2. To evaluate whether amount of gut microbiota necessary to improve gut health was associated with weight gain and growth in these children to support the casual mechanism behind this approach.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A three-arm randomized controlled trial in Dhaka's slum area is proposed. Infants at risk of stunting (-1 SD length-for-age z-score, LAZ) aged around 5 months are eligible for the study. Eligible children will be randomised to receive: 1) nutrition education on dietary diversity; 2) a combination of similar education plus daily supplementation of homemade yogurt; 3) a 'usual care' (control) group. We will recruit 120 children (40 per arm).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders

Arm Intervention/treatment
Active Comparator: Intervention 1
Nutrition education on dietary diversity.
Behavioral: Nutrition education

Nutrition Education on

  • Continued breastfeeding until two years of age
  • Food groups
  • Balanced diet
  • Introduction to locally available nutritious and low-cost foods
  • Amount and frequency of complementary feeding
  • Safe water, and
  • Handwashing with soap before feeding

Experimental: Intervention 2
A combination of similar education plus daily supplementation of homemade yogurt.
Dietary Supplement: Nutrition education+Homemade yogurt supplementation

Nutrition Education on

  • Continued breastfeeding until two years of age
  • Food groups
  • Balanced diet
  • Introduction to locally available nutritious and low-cost foods
  • Amount and frequency of complementary feeding
  • Safe water, and
  • Handwashing with soap before feeding

The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding.


Active Comparator: Usual care
Control group.
Other: Usual care
No intervention/ control group




Primary Outcome Measures :
  1. Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age. [ Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age ]
    Child length converted to z-score


Secondary Outcome Measures :
  1. Change from baseline (6 months) weight for age z-score (WAZ) at 9 months and 12 months of child age. [ Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age ]
    Child weight converted to z-score

  2. Change from baseline (6 months) mean head circumference at 9 months and 12 months of child age. [ Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age ]
    Child head circumference

  3. Change from baseline (6 months) mean concentration of fecal bio-markers at 9 months and 12 months of child age. [ Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age ]
    Concentration of neopterin, myeloperoxidase, and alpha 1 antitrypsin in stool samples.

  4. Change from baseline (6 months) proportion of children meeting food diversity scores at 9 months and 12 months of child age. [ Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age ]
    • Minimum dietary diversity (MDD): the proportion of children who received foods from 4 or more food categories on the previous day. This is a binary variable; children will be grouped into two - met MDD (score 1), did not meet MDD (score 0)
    • Minimum meal frequency (MMF): the proportion of children who received solid, semi-solid, or soft foods the minimum numbers of time or more on the previous day. The minimum acceptable number is 2 or more times until the age of 8 months and 3 or more times thereafter. This is a binary variable; children will be grouped into two - met MMF (score 1), did not meet MMF (score 0)
    • Minimum acceptable diet (MAD): the proportion of children who met both the MDD and MMF scores. This is a binary variable; children will be grouped into two - met MAD (score 1), did not meet MAD (score 0)



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants at risk of developing stunting aged 5 months (-1SD LAZ)
  2. All gender, religion, language and ethnicity
  3. Infants born through normal delivery or cesarean section
  4. Breastfeeding or non-breastfeeding

Exclusion Criteria:

  1. Stunting or wasting (<-2SD LAZ)
  2. Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT04067284    
Other Study ID Numbers: PR-19062
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Nutrition Disorders