SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project

NCT01824940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5280

Last updated 2018-07-26

No results posted yet for this study

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
  • Cornell University

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824940 on ClinicalTrials.gov