ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth

NCT04565314 | Unknown

• 1 other identifier: 21967
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Haydom Global Health Research Center in north central Tanzania represents an important rural setting for performing high-quality medical research in sub-Saharan Africa. The region around Haydom is agricultural (predominantly maize-based), is resource-poor and has a high degree of stunting among local infants-with 70% stunting by 18 months in the MAL-ED study and 50% in the ELICIT study (for Early Life Interventions for Childhood Growth and Development In Tanzania). While the causes of this stunting are multifactorial, a potential contributor is early-life nutritional deficiencies, including inadequate dietary protein. One likely source of low protein delivery to infants is from low intake among area mothers during lactation, with potential effects on breast milk protein content and child weight gain. The current study is a pilot study assessing our study team's ability to successfully deliver protein-containing food products (a balanced-energy protein supplement) to lactating mother is in the area and assessing whether consumption of these food products improves childhood growth in the 1st year of life. This is a pilot study because of the potential difficulties in distributing these products on a large scale for daily consumption. As such, we aim to demonstrate an effective distribution network, a means of assessing adherence, and measuring endpoints while gathering knowledge regarding community acceptance. The current pilot project will evaluate the effectiveness of distribution and adherence on approximately 100 mother/child dyads. If effective, a future project could involve a large enough sample to be powered to detect reasonable changes in linear growth. . So, while the current proposal is not adequately powered to prove a hypothesis, the hypothesis underlying the study design is that daily protein supplementation delivered as a balanced protein product (Plumpy'mum) to lactating mothers for 3 months during the period from 0-6 months post-natal life will result in an increase in infant length-for-age Z-score (LAZ) by end of treatment. LAZ will be compared to controls from prior studies in the area.

Conditions

Growth Failure; Stunting; Malnutrition; Protein Malnutrition

Keywords

protein; breast feeding; eggs; Ready-to-eat food; infant; growth; Tanzania

Outcome Measures

Primary Outcomes (1)

• Family perception of Plumpy'Mum

  Families will be queried about their impression of Plumpy'Mum

  at 3 months after enrollment

Secondary Outcomes (7)

• Child weight-for-age Z-score (WAZ) after 3 months of Plumpy'Mum use

  3 months

• Child head circumference-for-age Z-score (HCZ) after 3 months of Plumpy'Mum use

  3 months

• Child mid-upper arm circumference-for-age Z-score (MUAC-Z) after 3 months of Plumpy'Mum use

  3 months

• Child length-for-age Z-score (LAZ) after 3 months of Plumpy'Mum use

  3 months

• Adverse events

  3 months

Study Arms (1)

Plumpy'Mum

EXPERIMENTAL

Mother/child dyads will be enrolled at child age 0-3 months and mothers will immediately begin consuming a packet of Plumpy'Mum (or similar protein food product) daily. Plumpy'Mum will be provided by the study team to the mother, who will consume this however she desires (i.e., alone or with other food). Intervention will continue for 3 months. The rational is that Plumpy'Mum consumption will improve the quality of the breast milk the child is consuming, contributing to improved growth over time. Growth will be compared to historical controls from prior studies in the area.

Dietary Supplement: Plumpy'Mum

Interventions

Plumpy'Mum DIETARY_SUPPLEMENT

Mothers will consume Plumpy'Mum (one packet daily) from enrollment (child age 0-3 months) for 3 months.

Plumpy'Mum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age \>/= 18 years
• Current pregnancy or infant \</= 3 months

You may not qualify if:

• Maternal inability to adhere to protocol
• Multiple gestation
• Significant birth defect
• Maternal allergy to peanut, milk or soy
• Lack of breast feeding at enrollment (and lack of intention to continue breast feeding at time of enrollment

Sponsors & Collaborators

• University of Virginia: lead
• Haydom Lutheran Hospital: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Haydom Lutheran Hospital

Mbulu, Manyara Region, Tanzania

Location

MeSH Terms

Conditions

Failure to Thrive; Growth Disorders; Malnutrition; Kwashiorkor; Breast Feeding

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Nutrition Disorders; Nutritional and Metabolic Diseases; Severe Acute Malnutrition; Feeding Behavior; Behavior

Study Officials

• Mark D DeBoer, MD, MSc, MCR

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Participating mothers nursing children age 0-3 months at enrollment will receive 3 months of treatment with one packet of Plumpy'Mum.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 25, 2020
• Study Start: November 12, 2019
• Primary Completion: March 31, 2022
• Study Completion: August 1, 2022
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 1 year after publication of results
• Access Criteria: Contact PI to request

Locations

TA (1)