SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project
NCT01824940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5280
Last updated 2018-07-26
Summary
Globally, stunting affects 26% (165 million) of under-5-year children, underlies 15-17% of their mortality and leads to long-term cognitive deficits, fewer years and poorer performance in school, lower adult economic productivity, and a higher risk that their own children will also be stunted, perpetuating the problem into future generations. Stunting begins antenatally and peaks at 18-24 months of postnatal life, when mean length-for-age Z-score (LAZ) is about -2.0 among children living in Africa and Asia. Improving the diets of young children can reduce stunting, though, at best, only by about one-third. Frequent diarrheal illness has also been implicated. However, the effect of diarrhea on permanent stunting is relatively small, maybe because children grow at "catch-up" rates between illness episodes.
The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by a 2-part premise:
* A major cause of child stunting and anemia is Environmental Enteric Dysfunction (EED). EED is a subclinical disorder of the small intestine, which is virtually ubiquitous among asymptomatic people living in low-income settings throughout the world. EED is characterized by increased permeability which facilitates microbial translocation into the systemic circulation and triggers chronic immune activation.
* The primary cause of EED is infant ingestion of fecal microbes due to living in conditions of poor quality and quantity of water, sanitation, and hygiene (WASH).
Conditions
- Growth; Stunting, Nutritional
- Anemia
Interventions
- BEHAVIORAL
-
Standard care
Standard Care: * Exclusive breastfeeding promotion for all infants, birth to 6 months * Strengthened PMTCT (prevention of mother to child transmission of HIV) services * Strengthened Village Health Worker system
- OTHER
-
WASH
WASH: * Standard care interventions * Provide household ventilated pit latrine, water treatment solution, and monthly liquid soap, two hand-washing facilities and protected infant play space * Provide interpersonal communication interventions promoting feces disposal in a latrine, HWWS (hand washing with soap), drinking water treatment, hygienic weaning food preparation, and preventing babies from putting dirt and animal feces in their mouths.
- DIETARY_SUPPLEMENT
-
Infant and young child feeding
IYCF: * Standard care interventions * Provide 20 g/d Nutributter from 6-18 months * Provide interpersonal communication interventions promoting optimal use of locally available foods for complementary feeding after 6 months, continued breastfeeding and feeding during illness.
- OTHER
-
WASH and Nutrition
WASH AND IYCF interventions * Standard care interventions * All WASH interventions * All IYCF interventions
Sponsors & Collaborators
-
Ministry of Health and Child Welfare, Zimbabwe
collaborator OTHER -
Zvitambo
collaborator OTHER - collaborator OTHER
-
University of London
collaborator OTHER -
Bill and Melinda Gates Foundation
collaborator OTHER -
Department for International Development, United Kingdom
collaborator OTHER_GOV -
Wellcome Trust
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
Johns Hopkins Bloomberg School of Public Health
lead OTHER
Principal Investigators
-
Jean H Humphrey, ScD · Johns Hopkins University Bloomberg School of Public Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 15 Years
- Max Age
- 49 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2017-07-31
- Completion
- 2017-07-31
Countries
- Zimbabwe
Study Locations
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