SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project
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.
Growth; Stunting, Nutritional
Behavioral: Standard care
Dietary Supplement: Nutrition
Other: WASH and Nutrition
|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|
- 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
- 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).
|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)|
Placebo Comparator: Standard of Care
The Standard of Care interventions are the blanket interventions.
Behavioral: Standard care
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)
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
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:
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:
- Improved WASH (a ventilated pit latrine, hand washing facilities with soap, drinking water treatment, and health lessons to adopt improved hygiene behaviors)
- 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).
- Improved WASH and Infant Nutrition (both interventions)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824940
|Contact: Jean H Humphrey, ScDfirstname.lastname@example.org|
|Contact: Mdu Mbuya, PhDemail@example.com|
|Contact: Jean H Humphrey, ScD +263.4.850.732 firstname.lastname@example.org|
|Contact: Mdu Mbuya, PhD +263.4.850.732 email@example.com|
|Principal Investigator:||Jean H Humphrey, ScD||Johns Hopkins University Bloomberg School of Public Health|