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Balanced Protein-Energy Supplement in Pregnancy and Early Lactation on Birth Outcomes and Growth in Southern Nepal

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ClinicalTrials.gov Identifier: NCT03668977
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
Harvard University
Johns Hopkins University
Bill and Melinda Gates Foundation
University of California, Davis
Information provided by (Responsible Party):
George Washington University

Brief Summary:
This project will test the acceptability and efficacy of a balanced protein energy supplement for daily use during pregnancy and the first 6 months after delivery on the outcomes of pregnancy and growth of infants during the first 6 months of life. Approximately 1600 pregnant women from a district in southern Nepal will be recruited and randomly assigned to one of 4 groups, control in pregnancy & post-partum, supplementation in pregnancy & control post-partum, control in pregnancy & supplementation post-partum, or supplementation in pregnancy & post-partum. Pregnancies will be followed until delivery and the infants through 6 months of age. Outcomes of interest include birth size (weight and length), gestational age at delivery, maternal weight gain in pregnancy, maternal weight at 6 months post-partum, infant growth, and breast milk composition.

Condition or disease Intervention/treatment Phase
Pregnancy and Early Lactation Among Women Living in an Area Endemic for Malnutrition Dietary Supplement: Fortified balanced protein-energy. Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2 x 2 factorial design.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of a Balanced Protein-Energy Supplement in Pregnancy and Early Lactation on Reproductive Outcomes and Growth in Southern Nepal
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Routine care

In all four groups, the following antenatal and post-natal interventions will be offered:

  • Women encouraged to enroll in routine antenatal care at their local health post/center.
  • A clean birthing kit consisting of a clean blade, string, and plastic disc for cutting the cord, a plastic sheet, a bar of soap, and a tube of chlorhexidine ointment for application to the umbilical stump.
  • Women encouraged to deliver at a certified birthing facility and participate in the government's incentive scheme.
  • Nutritional, hygiene, and infant care counseling.
  • Tetanus toxoid (if needed) and iron-folic acid supplements.
Experimental: Supplementation-pregnancy
A daily fortified balanced protein-energy nutritional supplement beginning in the 2nd trimester and continuing throughout pregnancy. The exact form of this supplement will be selected in Phases one and two but its composition will be in conformance with the recommendations from the expert panel convened by the B&MGF on nutritional supplementation in pregnancy (Expert Consultation, 2016). We expect the calorie content to be between 300 and 400 Kcal/day.
Dietary Supplement: Fortified balanced protein-energy.
The exact form of this supplement will be selected in Phases one and two but its composition will be in conformance with the recommendations from the expert panel convened by the B&MGF on nutritional supplementation in pregnancy (Expert Consultation, 2016). We expect the calorie content to be between 300 and 400 Kcal/day.

Experimental: Supplementation-lactation
A daily fortified balanced protein-energy nutritional supplement beginning after delivery and continuing through 6 months post-partum. The exact form of this supplement will be selected in Phases one and two but its composition will be in conformance with the recommendations from the expert panel convened by the B&MGF on nutritional supplementation in pregnancy (Expert Consultation, 2016). We expect the calorie content to be between 300 and 400 Kcal/day.
Dietary Supplement: Fortified balanced protein-energy.
The exact form of this supplement will be selected in Phases one and two but its composition will be in conformance with the recommendations from the expert panel convened by the B&MGF on nutritional supplementation in pregnancy (Expert Consultation, 2016). We expect the calorie content to be between 300 and 400 Kcal/day.

Experimental: Supplementation-pregnancy & lactation
A daily fortified balanced protein-energy nutritional supplement beginning in the 2nd trimester and continuing through 6 months post-partum. The exact form of this supplement will be selected in Phases one and two but its composition will be in conformance with the recommendations from the expert panel convened by the B&MGF on nutritional supplementation in pregnancy (Expert Consultation, 2016). We expect the calorie content to be between 300 and 400 Kcal/day.
Dietary Supplement: Fortified balanced protein-energy.
The exact form of this supplement will be selected in Phases one and two but its composition will be in conformance with the recommendations from the expert panel convened by the B&MGF on nutritional supplementation in pregnancy (Expert Consultation, 2016). We expect the calorie content to be between 300 and 400 Kcal/day.




Primary Outcome Measures :
  1. Small-for-Gestational-Age (<10th centile weight(g) for gestational age) [ Time Frame: Within 72 hours of birth. ]
    The incidence of SGA (<10th centile) among live born infants whose birth weight(g) is measured within 72 hours of delivery. Comparison is between those supplemented during pregnancy versus those not.

  2. Stunting (Length-for-Age <-2 Z scores). [ Time Frame: 6 months of age ]
    Prevalence of Length(cm)-for-age Z score of >-2 among infants at 6 months of age. Comparison is between women supplemented during post-partum period versus those not.


Secondary Outcome Measures :
  1. Short-for-Gestational-Age (<10th centile height(cm) for gestational age) [ Time Frame: Within 72 hours of birth. ]
    The incidence of ShGA (<10th centile among live born infants whose birth length(cm) is measured within 72 hours of delivery.

  2. Small-for-Gestational-Age (<3rd centile weight(g) for gestational age) [ Time Frame: Within 72 hours of birth. ]
    The incidence of SGA (<3rd centile) among live born infants whose birth weight(g) is measured within 72 hours of delivery.

  3. Short-for-Gestational-Age (<3rd centile height(cm) for gestational age) [ Time Frame: Within 72 hours of birth. ]
    The incidence of ShGA (<3rd centile) among live born infants whose birth length(cm) is measured within 72 hours of delivery.

  4. Birth weight [ Time Frame: Within 72 hours of birth. ]
    Mean birthweight (g) among live born infants whose birthweight is measured within 72 hours of delivery.

  5. Low birth weight (<2500 g) [ Time Frame: Within 72 hours of birth. ]
    Proportion low birth weight (<2500 g) among live born infants whose birth weight is measured within 72 hours of delivery.

  6. Birth Length [ Time Frame: Within 72 hours of birth. ]
    Mean birth length (cm) among live born infants whose birth length is measured within 72 hours of delivery.

  7. Gestational age [ Time Frame: Birth ]
    Mean gestational age(weeks) among live born infants.

  8. Proportion preterm (<37 weeks) [ Time Frame: Birth ]
    Proportion preterm (<37 weeks gestation) among live born infants.

  9. Length-for-age [ Time Frame: 6 & 12 months of age. ]
    Mean Length(cm)-for-Age at 6 and 12 months of age among live born infants based on the WHO growth reference standards (WHO, 2006).

  10. Prevalence of stunting [ Time Frame: 12 months of age. ]
    Prevalence of Length(cm)-for-Age <-2 Z scores at 12 months of age among live born infants based on the WHO growth reference standards (WHO, 2006).

  11. Weight-for-age [ Time Frame: 6 & 12 months of age. ]
    Mean Weight(g)-for-Age Z score at 6 & 12 months of age among live born infants based on the WHO growth reference standards (WHO, 2006).

  12. Prevalence of underweight [ Time Frame: 6 & 12 months of age. ]
    Prevalence of Weight(g)-for-Age <-2 Z scores at 6 & 12 months of age among live born infants based on the WHO growth reference standards (WHO, 2006).

  13. Weight-for-length [ Time Frame: 6 & 12 months of age. ]
    Mean Weight(g)-for-Length(cm) Z score at 6 & 12 months of age among live born infants based on the WHO growth reference standards (WHO, 2006).

  14. Prevalence of wasting [ Time Frame: 6 & 12 months of age. ]
    Prevalence of Weight(g)-for-Length <-2 Z scores at 6 & 12 months of age among live born infants based on the WHO growth reference standards (WHO, 2006).

  15. Maternal weight (kg). [ Time Frame: Late pregnancy visit (~ 36 weeks) & 6 months post-partum. ]
    Mean maternal weight (kg) at late pregnancy visit (~ 36 weeks) & 6 months post-partum.

  16. Maternal Body Mass Index (BMI) [ Time Frame: Late pregnancy visit (~ 36 weeks) & 6 months post-partum. ]
    BMI (Weight(kg/Height(m)*2) at late pregnancy visit (~ 36 weeks) & 6 months post-postpartum

  17. Breast milk micro-nutrient and macro-nutrient status [ Time Frame: 1-2 months and 3-4 months after delivery. ]
    Breast milk composition at 1-2 & 3-4 months after delivery.



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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all women who become pregnant during a 9-month period in a set of Village Development Committees (VDCs) in Sarlahi District, Nepal.

Exclusion Criteria:

  • Women who do not intend to deliver their child in the study area.
  • Women who are allergic to milk, nuts or soy.
  • Women who are unwilling to commit to daily consumption of the nutritional supplement if they are randomized to an active treatment arm.
  • Women who refuse to provide consent.

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): NCT03668977


Contacts
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Contact: James M Tielsch, PhD 202-994-4124 jtielsch@gwu.edu
Contact: Luke C Mullany, PhD 410-502-2629 lmullan1@jhu.edu

Locations
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Nepal
Nepal Nutrition Intervention Project - Sarlahi Recruiting
Hariaun, Sarlahi District, Nepal
Contact: Subarna K Khatry, MD    977-1-55504914    skhatry@wlink.com.np   
Sub-Investigator: Joanne Katz, ScD         
Sub-Investigator: Sheila Isanaka, PhD         
Sub-Investigator: Saskia dePee, PhD         
Sub-Investigator: Juliette Bedford, PhD         
Sub-Investigator: Swaraj Rajbhandari, MD         
Sub-Investigator: Steven LeClerq, MPH         
Sub-Investigator: Lindsey Allen, PhD         
Sub-Investigator: Tsering Lama, PhD         
Sponsors and Collaborators
George Washington University
Harvard University
Johns Hopkins University
Bill and Melinda Gates Foundation
University of California, Davis
Investigators
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Principal Investigator: James M Tielsch, PhD George Washington University
Principal Investigator: Luke C Mullany, PhD Johns Hopkins University
Principal Investigator: Subarna K Khatry, MD Nepal Nutrition Intervention Project Sarlahi

Publications:
Bernard HR. Research methods in anthropology. 2nd ed. Thousand Oaks, CA: Sage Publications; 2006.
Charmaz K. Constructing grounded theory: Sage; 2014.
Christian P, Bunjun Srihari S, et al. Eating down in pregnancy: exploring food-related beliefs and practices of pregnancy in rural Nepal. Ecology of food and nutrition. 2006; 45(4):253-78.
Consultants SR. Dedoose web application for managing, analyzing, and presenting qualitative and mixed methods research data. 7.0.23 ed. Los Angeles, CA: SocioCultural Research Consultants, LLC; 2016.
Dominici F, Zeger SL, Parmigiani G, et al. Estimating percentile-specific effects: a case study of micronutrient supplementation, birth weight, and infant mortality. J R Stat Soc Ser C Appl Stat. 2006; 50:1-20.
Expert Consultation held at The Bill and Melinda Gates Foundation. Framework and specifications for the nutritional composition of a food supplement for pregnant and lactating women (PLW) in undernourished and low income settings. Bill and Melinda Gates Foundation, 2016 Sept 19-20, Seattle, WA.
Glesne C, Peshkin A. Becoming qualitative researchers: an introduction. White Plains, NY: Longman; 1992.
Hayes RJ, Moulton LH. Cluster Randomized Trials. Boca Raton FL: Chapman & Hall/CRC, 2009.
Lawless HT, Heymann H. Sensory evaluation of food: principles and practices. 2nd ed. New York: Springer; 2010. xxiii, 596 p. p.
Ministry of Health, Nepal; New ERA; and ICF. 2017. Nepal Demographic and Health Survey 2016: Key Indicators. Kathmandu, Nepal: Ministry of Health, Nepal.
Ridder HG, Miles MB, Huberman AM, Saldana J. Qualitative data analysis: a methods source book. 3rds ed. Thousand Oaks, CA: Sage Publications; 2014.
WHO. Handbook for Good Clincial Research Practice (GCP): Guidance for Implementation. World Health Organization, Geneva, 2005.
World Health Organization. WHO Child Growth Standards: Methods and development: Length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: methods and development. World Health Organization, Geneva, 2006.
World Health Organization (WHO). WHO recommendations on antenatal care for a positive pregnancy experience. WHO, Geneva, 2016.

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Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT03668977     History of Changes
Other Study ID Numbers: 081739
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification will be available on a Gates Foundation supported website.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Beginning 12 months following article publication. No end date.
Access Criteria: Proposals should be directed to jtielsch@gwu.edu. To gain access, data requestors will need to sign a data access agreement. Data will be posted after 12 months to a website supported by the Bill and Melinda Gates Foundation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders