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SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project (SHINE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01824940
First Posted: April 5, 2013
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health and Child Care, Zimbabwe
Zvitambo
Cornell University
University of London
Bill and Melinda Gates Foundation
Department for International Development, United Kingdom
Wellcome Trust
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jean Humphrey, Johns Hopkins Bloomberg School of Public Health
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Masking Description:
Given the nature of the intervention, masking to treatment group is not possible.
Primary Purpose: Prevention
Official Title: Sanitation, Hygiene, Infant Nutrition Efficacy Project

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 5280
Study Start Date: November 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: June 2017 (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 of mother to child transmission of HIV) 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 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.
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

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes 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 during pregnancy, and their live born infants. A total of 5280 women will be enrolled.

Inclusion Criteria:

Pregnant women residing in the study districts, whose pregnancy is confirmed by a urine pregnancy test.

Exclusion Criteria:

  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824940


Locations
Zimbabwe
Zvitambo
Harare, Zimbabwe
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Ministry of Health and Child Care, Zimbabwe
Zvitambo
Cornell University
University of London
Bill and Melinda Gates Foundation
Department for International Development, United Kingdom
Wellcome Trust
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jean H Humphrey, ScD Johns Hopkins University Bloomberg School of Public Health
  More Information

Additional Information:
Publications:
Humphrey JH. Child undernutrition, tropical enteropathy, toilets, and handwashing. Lancet. 2009 Sep 19;374(9694):1032-5. doi: 10.1016/S0140-6736(09)60950-8. Review.
Prendergast AJ, Rukobo S, Chasekwa B, Mutasa K, Ntozini R, Mbuya MN, Jones A, Moulton LH, Stoltzfus RJ, Humphrey JH. Stunting is characterized by chronic inflammation in Zimbabwean infants. PLoS One. 2014 Feb 18;9(2):e86928. doi: 10.1371/journal.pone.0086928. eCollection 2014.
Paul KH, Muti M, Chasekwa B, Mbuya MN, Madzima RC, Humphrey JH, Stoltzfus RJ. Complementary feeding messages that target cultural barriers enhance both the use of lipid-based nutrient supplements and underlying feeding practices to improve infant diets in rural Zimbabwe. Matern Child Nutr. 2012 Apr;8(2):225-38. doi: 10.1111/j.1740-8709.2010.00265.x. Epub 2010 Aug 4.
Mbuya MN, Humphrey JH, Majo F, Chasekwa B, Jenkins A, Israel-Ballard K, Muti M, Paul KH, Madzima RC, Moulton LH, Stoltzfus RJ. Heat treatment of expressed breast milk is a feasible option for feeding HIV-exposed, uninfected children after 6 months of age in rural Zimbabwe. J Nutr. 2010 Aug;140(8):1481-8. doi: 10.3945/jn.110.122457. Epub 2010 Jun 23.
Ngure FM, Humphrey JH, Mbuya MN, Majo F, Mutasa K, Govha M, Mazarura E, Chasekwa B, Prendergast AJ, Curtis V, Boor KJ, Stoltzfus RJ. Formative research on hygiene behaviors and geophagy among infants and young children and implications of exposure to fecal bacteria. Am J Trop Med Hyg. 2013 Oct;89(4):709-16. doi: 10.4269/ajtmh.12-0568. Epub 2013 Sep 3.
Mupfudze TG, Stoltzfus RJ, Rukobo S, Moulton LH, Humphrey JH, Prendergast AJ; SHINE Project Team. Hepcidin decreases over the first year of life in healthy African infants. Br J Haematol. 2014 Jan;164(1):150-3. doi: 10.1111/bjh.12567. Epub 2013 Sep 20.
Ngure FM, Reid BM, Humphrey JH, Mbuya MN, Pelto G, Stoltzfus RJ. Water, sanitation, and hygiene (WASH), environmental enteropathy, nutrition, and early child development: making the links. Ann N Y Acad Sci. 2014 Jan;1308:118-28. doi: 10.1111/nyas.12330. Review.
Palha De Sousa CA, Brigham T, Chasekwa B, Mbuya MN, Tielsch JM, Humphrey JH, Prendergast AJ. Dosing of praziquantel by height in sub-Saharan African adults. Am J Trop Med Hyg. 2014 Apr;90(4):634-7. doi: 10.4269/ajtmh.13-0252. Epub 2014 Mar 3.
Gough EK, Moodie EE, Prendergast AJ, Johnson SM, Humphrey JH, Stoltzfus RJ, Walker AS, Trehan I, Gibb DM, Goto R, Tahan S, de Morais MB, Manges AR. The impact of antibiotics on growth in children in low and middle income countries: systematic review and meta-analysis of randomised controlled trials. BMJ. 2014 Apr 15;348:g2267. doi: 10.1136/bmj.g2267. Review.
Desai A, Mbuya MN, Chigumira A, Chasekwa B, Humphrey JH, Moulton LH, Pelto G, Gerema G, Stoltzfus RJ; SHINE Study Team. Traditional oral remedies and perceived breast milk insufficiency are major barriers to exclusive breastfeeding in rural Zimbabwe. J Nutr. 2014 Jul;144(7):1113-9. doi: 10.3945/jn.113.188714. Epub 2014 May 14.
Jones AD, Rukobo S, Chasekwa B, Mutasa K, Ntozini R, Mbuya MN, Stoltzfus RJ, Humphrey JH, Prendergast AJ. Acute illness is associated with suppression of the growth hormone axis in Zimbabwean infants. Am J Trop Med Hyg. 2015 Feb;92(2):463-70. doi: 10.4269/ajtmh.14-0448. Epub 2014 Dec 22.
Mupfudze TG, Stoltzfus RJ, Rukobo S, Moulton LH, Humphrey JH, Prendergast AJ; SHINE Trial Team, Jones AD, Manges A, Mangwadu G, Maluccio JA, Mbuya MN, Ntozini R, Tielsch JM. Plasma Concentrations of Hepcidin in Anemic Zimbabwean Infants. PLoS One. 2015 Aug 7;10(8):e0135227. doi: 10.1371/journal.pone.0135227. eCollection 2015.
Gough EK, Stephens DA, Moodie EE, Prendergast AJ, Stoltzfus RJ, Humphrey JH, Manges AR. Linear growth faltering in infants is associated with Acidaminococcus sp. and community-level changes in the gut microbiota. Microbiome. 2015 Jun 13;3:24. doi: 10.1186/s40168-015-0089-2. eCollection 2015. Erratum in: Microbiome. 2016;4:5.
Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team, Humphrey JH, Jones AD, Manges A, Mangwadu G, Maluccio JA, Mbuya MN, Moulton LH, Ntozini R, Prendergast AJ, Stoltzfus RJ, Tielsch JM. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Rationale, Design, and Methods. Clin Infect Dis. 2015 Dec 15;61 Suppl 7:S685-702. doi: 10.1093/cid/civ844.
Mbuya MN, Tavengwa NV, Stoltzfus RJ, Curtis V, Pelto GH, Ntozini R, Kambarami RA, Fundira D, Malaba TR, Maunze D, Morgan P, Mangwadu G, Humphrey JH; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Design of an Intervention to Minimize Ingestion of Fecal Microbes by Young Children in Rural Zimbabwe. Clin Infect Dis. 2015 Dec 15;61 Suppl 7:S703-9. doi: 10.1093/cid/civ845.
Desai A, Smith LE, Mbuya MN, Chigumira A, Fundira D, Tavengwa NV, Malaba TR, Majo FD, Humphrey JH, Stoltzfus RJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. The SHINE Trial Infant Feeding Intervention: Pilot Study of Effects on Maternal Learning and Infant Diet Quality in Rural Zimbabwe. Clin Infect Dis. 2015 Dec 15;61 Suppl 7:S710-5. doi: 10.1093/cid/civ846.
Ntozini R, Marks SJ, Mangwadu G, Mbuya MN, Gerema G, Mutasa B, Julian TR, Schwab KJ, Humphrey JH, Zungu LI; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Using Geographic Information Systems and Spatial Analysis Methods to Assess Household Water Access and Sanitation Coverage in the SHINE Trial. Clin Infect Dis. 2015 Dec 15;61 Suppl 7:S716-25. doi: 10.1093/cid/civ847.
Prendergast AJ, Humphrey JH, Mutasa K, Majo FD, Rukobo S, Govha M, Mbuya MN, Moulton LH, Stoltzfus RJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Assessment of Environmental Enteric Dysfunction in the SHINE Trial: Methods and Challenges. Clin Infect Dis. 2015 Dec 15;61 Suppl 7:S726-32. doi: 10.1093/cid/civ848.
Mbuya MN, Jones AD, Ntozini R, Humphrey JH, Moulton LH, Stoltzfus RJ, Maluccio JA; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Theory-Driven Process Evaluation of the SHINE Trial Using a Program Impact Pathway Approach. Clin Infect Dis. 2015 Dec 15;61 Suppl 7:S752-8. doi: 10.1093/cid/civ716.
Mbuya MN, Humphrey JH. Preventing environmental enteric dysfunction through improved water, sanitation and hygiene: an opportunity for stunting reduction in developing countries. Matern Child Nutr. 2016 May;12 Suppl 1:106-20. doi: 10.1111/mcn.12220. Epub 2015 Nov 6. Review.
Smith LE, Prendergast AJ, Turner PC, Humphrey JH, Stoltzfus RJ. Aflatoxin Exposure During Pregnancy, Maternal Anemia, and Adverse Birth Outcomes. Am J Trop Med Hyg. 2017 Apr;96(4):770-776. doi: 10.4269/ajtmh.16-0730. Review.

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 ( U.S. NIH Grant/Contract )
First Submitted: March 27, 2012
First Posted: April 5, 2013
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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


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