Nutributter Programming to Prevent Undernutrition: an Evaluation

NCT ID: NCT01552512

Last Updated: 2018-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Undernutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MSPP Integrated Package

Participants in this arm only receive the standard care offered by the Ministry of Health (MSPP)called the Integrated Package. During the trial, they do not receive Nutributter.

Group Type NO_INTERVENTION

No interventions assigned to this group

Nutributter 3 Months, Integrated Package

Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.

Group Type EXPERIMENTAL

Nutributter Program

Intervention Type DIETARY_SUPPLEMENT

Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.

Integrated Package

Intervention Type OTHER

The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).

Nutributter 6 Months, Integrated Package

Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.

Group Type EXPERIMENTAL

Nutributter Program

Intervention Type DIETARY_SUPPLEMENT

Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.

Integrated Package

Intervention Type OTHER

The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutributter Program

Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.

Intervention Type DIETARY_SUPPLEMENT

Integrated Package

The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nutriset

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infants 6 to 12 months old
* Lives in Fort San Michel

Exclusion Criteria

* Moderately or severely malnourished
* Peanut allergy
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role collaborator

World Bank

OTHER

Sponsor Role collaborator

United Nations World Food Programme (WFP)

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lora Iannotti, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital Fort San Michel

Cap-Haïtien, , Haiti

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Haiti

References

Explore related publications, articles, or registry entries linked to this study.

Iannotti LL, Dulience SJ, Green J, Joseph S, Francois J, Antenor ML, Lesorogol C, Mounce J, Nickerson NM. Linear growth increased in young children in an urban slum of Haiti: a randomized controlled trial of a lipid-based nutrient supplement. Am J Clin Nutr. 2014 Jan;99(1):198-208. doi: 10.3945/ajcn.113.063883. Epub 2013 Nov 13.

Reference Type DERIVED
PMID: 24225356 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FSM-001-201101760

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Power of Peanuts School Feeding
NCT04349007 COMPLETED NA