SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project (SHINE)
|ClinicalTrials.gov Identifier: NCT01824940|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2013
Last Update Posted : March 3, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Growth; Stunting, Nutritional Anemia||Behavioral: Standard care Other: WASH Dietary Supplement: Nutrition Other: WASH and Nutrition||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5280 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Given the nature of the intervention, masking to treatment group is not possible.|
|Official Title:||Sanitation, Hygiene, Infant Nutrition Efficacy Project|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||March 2018|
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 and young child 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:
- Infant length at 18 months [ Time Frame: 18 months of age ]Recumbent length measured by length board
- Infant hemoglobin at 18 months [ Time Frame: 18 months ]Measured by Hemocue
- Infant environmental enteric dysfunction [ Time Frame: 1, 3, 6, 12 and 18 months of age ]Assessed in a subgroup of infants recruited to the EED substudy by assessing domains of the hypothesized EED pathway using biomarkers of intestinal structure and function (inflammation, regeneration, absorption and permeability); microbial translocation; systemic inflammation; and hormonal determinants of growth and anemia
- Infant weight, mid-upper arm circumference and head circumference [ Time Frame: At 18 months, and (with length) at intermediate time-points of 1, 3, 6 and 12 months ]Measured by standardized anthropometry protocols at each age
- To describe the Program Impact Pathways (PIP) linking implementation of each randomized intervention (WASH and IYCF) with length and hemoglobin concentrations [ Time Frame: Throughout follow-up ]Assessment of quality of VHW training and supervision; VHW Capacity, defined as a composite of attained knowledge, goal setting capacity, and achieved performance; Fidelity of intervention implementation, defined as degree of conformance with protocol specifications for both VHW and mother; Attained maternal knowledge and skills assessed by questionnaire and observation; Uptake or adoption of promoted behaviors by mothers and their households assessed by questionnaire and observation.
- Exclusive breastfeeding [ Time Frame: First 6 months of life ]To describe the prevalence of exclusive breastfeeding among all infants enrolled in the trial by maternal/infant HIV status.
- To evaluate the effect of the IYCF intervention on uptake of improved infant feeding practices by maternal/infant HIV status [ Time Frame: 6-18 months of age ]Infant diet quality as assessed by World Health Organization IYCF indicators ; infant nutrient intake from complementary foods assessed by 24 hour dietary recall; appropriate use of Nutributter from 6 to 18 months.
- To evaluate the effect of the WASH intervention on the 5 key behaviors it promotes by maternal/infant HIV status [ Time Frame: Throughout follow-up ]Proper disposal of animal and human feces; Handwashing with soap after fecal contact; Point-of-use chlorination of drinking water; Protecting children from ingestion of dirt and feces; Feeding baby freshly prepared foods, or reheating leftover food.
- Relative contributions of diarrhea vs EED [ Time Frame: Birth to 18 months ]To model the relative contributions of diarrheal disease and EED in mediating the effects of improved WASH on child length and hemoglobin concentrations, stratified by maternal/infant HIV status.
- To measure the strength of association between other potential causes of stunting and anemia (other than poor WASH or IYCF) with linear growth and hemoglobin [ Time Frame: Throughout follow-up ]Maternal schistosomiasis infection during pregnancy; Maternal HIV infection together with adherence to antiretroviral and cotrimoxazole regimens during pregnancy and lactation; Infant HIV infection or exposure, together with adherence to antiretroviral and/or cotrimoxazole regimens; Exposure to dietary mycotoxin contamination by the mother during pregnancy and lactation, and by the infant during complementary feeding.
- Infant diarrhea prevalence, incidence and severity [ Time Frame: 1 month to 18 months of age ]Assessed by 7-day morbidity history in all infants, and by daily morbidity diary in a subgroup of infants
- Child neurodevelopment [ Time Frame: 24 months of age ]Assessed by MacArthur-Bates Communication Developmental Inventory; Malawi Development Test (MDAT); A not B task; Delayed inhibition task; and Caregiver Child Interaction assessment in a subgroup of children
- Prevalence of mycotoxin exposure among mothers and infants [ Time Frame: Maternal samples assessed at baseline; infant samples assessed birth to 18 months ]Detectable AFB1-lysine in plasma and detectable AFM1 in urine; detectable Fumonisin B1 in urine; detectable deoxynivalenol in urine; detectable zearalenone in urine; detectable ochratoxin A in urine; detectable T-2 in urine
- MAternal and infant microbiota [ Time Frame: Maternal samples from baseline and 1 month postpartum; infant samples birth to 18 months of age ]16S rRNA and whole genome sequencing of DNA and RNA from stool to define th composition and function of the microbial community that inhabits the human intestine.
- Infant rotavirus vaccine and polio vaccine immunogenicity [ Time Frame: 1 and 3 months of age ]Measurement of rotavirus IgA titre in plasma, measurement of polio virus IgA titre in plasma
- Adverse birth outcomes: miscarriage, still birth, small for gestational age, preterm delivery, neonatal death [ Time Frame: Maternal pregnancy exposures, infant outcomes through 1 month postpartum ]Association of maternal exposures during pregnancy (EED, anemia, mycotoxin exposure, HIV infection, schistosomiasis infection) on each adverse birth outcome
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824940
|Principal Investigator:||Jean H Humphrey, ScD||Johns Hopkins University Bloomberg School of Public Health|