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SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborators:
Ministry of Health and Child Welfare, Zimbabwe
Zvitambo
Cornell University
University of London
Bill and Melinda Gates Foundation
Department for International Development, United Kingdom
Wellcome Trust
Swiss Development Cooperation
Information provided by (Responsible Party):
Jean Humphrey, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01824940
First received: March 27, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

In less developed countries, 1/3 of under-2-year old children are stunted (short stature for age). This early childhood stunting causes about one-fifth of all under-5-y child deaths in developing countries and, because brain development mirrors linear growth, leads to long-term cognitive deficits, fewer years and poorer performance in school, lower adult economic productivity, and a higher risk that their children will also be stunted, perpetuating the problem into future generations. The growth failure causing stunting occurs during pregnancy and the first two years after birth; after age 2 there is little or no recovery. 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 study will test the hypothesis that a major cause of child stunting and anemia is environmental enteropathy (EE), an asymptomatic condition of the small intestine caused by exposure to poor environmental sanitation. Environmental enteropathy is extremely common among people living in developing countries. During Environmental enteropathy, nutrient absorption is reduced and intestinal wall "leaks" allowing large numbers of bacteria into the blood stream which causes chronic low-grade infection. We hypothesize that children with Environmental enteropathy use much of the nutrients they eat to fight these chronic low-grade infections, using less nutrients from their diet for growing.


Condition Intervention
Growth; Stunting, Nutritional
Anemia
Behavioral: Standard care
Other: WASH
Dietary Supplement: Nutrition
Other: WASH and Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sanitation, Hygiene, Infant Nutrition Efficacy Project

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Infant length at 18 months [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    recumbent length measured by length board

  • Infant hemoglobin at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Measured by hemocue


Secondary Outcome Measures:
  • Infant diarrhea prevalence [ Time Frame: estimated diarrhea prevalence between birth and 18 months of age ] [ Designated as safety issue: No ]
    Assessed by 7-day morbidity history

  • Infant fever [ Time Frame: fever incidence between birth and 18 months of age ] [ Designated as safety issue: No ]
    Assessed by 7-day morbidity history

  • Cough with rapid breathing [ Time Frame: cough incidence between birth and 18 months of age ] [ Designated as safety issue: No ]
    by 7-day history

  • Infant Environmental enteropathy [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    Assessed in a subsample of 1600 infants. These characteristics (laboratory test) of EE will be measured: Gut permeability (lactulose:mannitol test), Gut inflammation (fecal neopterin); Gut microbial translocation (plasma endotoxin core antibody, LPS (lipopolysaccharide), sol CD14); immune activation (proinflammatory cytokines, acute phase proteins, immunoglobulins); growth hormone axis (IGF-1 and IGF-1(insulin-like growth factor):IGFBP3 ratio).


Estimated Enrollment: 4800
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard of Care
The Standard of Care interventions are the blanket interventions.
Behavioral: Standard care

Standard Care:

  • Exclusive breastfeeding promotion for all infants, birth to 6 months
  • Strengthened PMTCT (prevention from mother to child transmission) services
  • Strengthened Village Health Worker system
Active Comparator: WASH

One of two active interventions to be studied in this 2X2 (two by two) Factorial trial:

Intervention 1: a package of interventions to improve household sanitation and hygiene (WASH)

Other: WASH

WASH:

  • Standard care interventions
  • Provide household ventilated pit latrine, water treatment solution, and monthly liquid soap, two hand-washing facilities.
  • 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.
Active Comparator: Nutrition

One of two active interventions to be studied in this 2X2 Factorial trial:

Intervention 2: a package of interventions to improve infant feeding (IYCF)

Dietary Supplement: Nutrition

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.
Active Comparator: WASH and Nutrition
This arm receives a combination of all standard care interventions, all WASH and all IYCF interventions.
Other: WASH and Nutrition

Sanitation/Hygiene AND Nutrition:

  • Standard care interventions
  • All WASH interventions
  • All IYCF interventions

Detailed Description:

The Sanitation Hygiene Infant Nutrition Efficacy ("SHINE") study will test the effects of two packages of interventions: 1) improved water, sanitation and hygiene (WASH) and 2) improved infant nutrition (IN) on child stunting and anemia in the first 18 months of life. The study will be conducted in rural Zimbabwe where WASH is poor, food insecurity high, and where about 15% of pregnant women are infected with HIV. The study will enroll 4,800 women early in pregnancy and follow them and their infants until 18 months after delivery. The study will be a cluster-randomized controlled trial: two entire districts in central Zimbabwe have been divided into 212 geographic areas, each of about 100 households. The areas will be randomly allocated (that is, assigned by according to chance like the flip of a coin) to one of four interventions:

  1. Improved WASH (a ventilated pit latrine, hand washing facilities with soap, drinking water treatment, and health lessons to adopt improved hygiene behaviors)
  2. Improved Infant Nutrition (health lessons on best infant feeding practices and a nutritional supplement to be fed daily to babies from 6 to 18 months).
  3. Improved WASH and Infant Nutrition (both interventions)
  4. Standard of Care

All women living in the two districts who become pregnant during the recruitment period of the study will be invited to enroll. They will receive one of the 4 packages of interventions according to the area where they live. Health lessons will be given by Village Health Workers. Latrines and hand washing facilities will be constructed by building teams managed by Oxfam, a non-government organization active in WASH in Zimbabwe. Mothers will be followed up by research nurses at 7 months gestation, and at 1, 3, 6, 12, and 18 months after delivery. Primary outcomes are infant height and hemoglobin at 18 months of age.

In a sub-sample of 1600 mothers and babies the investigators will also collect samples of stool and blood and conduct a special sugar absorption test collecting urine. These samples will be tested for factors of Environmental Enteropathy (EE) - factors that indicate the health of the intestinal wall. The investigators will also ask these mothers to record all diarrhea, respiratory infection, and fever illnesses that the child has between 1 month and 18 months of age. This sub-study will investigate whether improved WASH reduces EE and whether reduced environmental enteropathy is, in turn associated with improved growth and reduced anemia.

Since the mothers enrolled in SHINE will have lived in unsanitary living conditions throughout their lives, it is anticipated that most will have some degree of EE themselves. It is hypothesized that resulting chronic inflammation contributes to adverse birth outcomes. This question will be investigated through an observational design. For all mothers enrolled in SHINE, the sugar absorption test described above will be conducted and specimens of urine, stool and blood collected and archived at the 10-12 week gestation visit for later assessment of EE indicators. The association of severity of EE with risk of adverse birth outcomes (low birth length and weight; miscarriage, stillbirth, and premature delivery) will be assessed.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Study participants will be women who are rural residents of Chirumanzu or Shurugwi districts in Zimbabwe and who become pregnant during the enrollment period of the trial and are identified and consent to participation before 14 weeks of gestation, and their live born infants. A total of 4800 women will be enrolled.

Inclusion Criteria:

Women residing in the study districts under monthly prospective pregnancy surveillance of a Village Health Worker, who have a negative pregnancy test followed by a positive pregnancy test.

Exclusion Criteria:

  • Women residing in the study districts who were already pregnant when trial recruitment begins
  • Women who are >14 weeks gestation at the time of enrollment
  • Women residing in the study districts who become pregnant during the enrollment period but do not consent to join the trial
  • Women who reside in urban areas of these two districts
  • Infants with major non-fatal abnormalities will not be excluded from study procedures, but will be excluded from the final analytic sample if the abnormality is likely to directly affect gut health/function or stature (e.g. neural tube defects, cerebral palsy, Down syndrome)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824940

Contacts
Contact: Jean H Humphrey, ScD +263.4.850.732 jhumphrey@zvitambo.co.zw
Contact: Mdu Mbuya, PhD +263.4.850.732 mmbuya@zvitambo.co.zw

Locations
Zimbabwe
Zvitambo Recruiting
Harare, Zimbabwe
Contact: Jean H Humphrey, ScD    +263.4.850.732    jhumphrey@zvitambo.co.zw   
Contact: Mdu Mbuya, PhD    +263.4.850.732    mmbuya@zvitambo.co.zw   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Ministry of Health and Child Welfare, Zimbabwe
Zvitambo
Cornell University
University of London
Bill and Melinda Gates Foundation
Department for International Development, United Kingdom
Wellcome Trust
Swiss Development Cooperation
Investigators
Principal Investigator: Jean H Humphrey, ScD Johns Hopkins University Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Jean Humphrey, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01824940     History of Changes
Other Study ID Numbers: IRB00004205, R01HD060338
Study First Received: March 27, 2012
Last Updated: June 19, 2013
Health Authority: Zimbabwe: Medical Research Council

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Cluster randomized trial
Nutrition
Water Sanitation Hygiene
Environmental enteropathy

ClinicalTrials.gov processed this record on November 20, 2014