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Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia

NCT ID: NCT05073562

Last Updated: 2021-11-22

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2021-12-31

Brief Summary

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The purpose of this study is to evaluate the feasibility and effectiveness of weekly iron and folic acid (IFA) supplementation and one-time deworming treatment at the community level in improving hemoglobin levels among adolescent girls in Liberia, West Africa, and to assess the feasibility and effectiveness of a targeted nutrition education program in improving nutrition knowledge, attitudes, and practices in the same population.

Detailed Description

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Conditions

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Nutritional Anemia Nutritional Deficiency Iron Deficiency Anemia Treatment Folic Acid Deficiency Anemia, Dietary Adolescent Development Knowledge, Attitudes, Practice Food Habits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Nutrition+ Intervention

This group will receive a structured nutrition education package provided by Community Health Assistants (CHAs) based on a handbook on nutrition education developed by UNICEF with collaboration from the Liberia Ministry of Health. The structured nutrition education package will focus on four key areas: causes and prevention of anemia, healthy eating and food choices, hand washing, and physical exercise. Participants in the intervention group will also receive IFA supplementation on a weekly basis for the duration of the study, and a one-time oral deworming treatment (mebendazole), which will be administered once at the beginning of the study.

Group Type EXPERIMENTAL

Iron and folic acid (IFA) supplementation

Intervention Type DIETARY_SUPPLEMENT

Weekly IFA supplementation for duration of the study.

Targeted nutrition education

Intervention Type BEHAVIORAL

Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)

Mebendazole Pill

Intervention Type DRUG

One-time deworming treatment with mebendazole.

Control group - standard services only

This group will receive only the current package of basic nutrition services provided at the health facility and at community level by health workers and CHAs, respectively.

Group Type ACTIVE_COMPARATOR

Standard nutrition services

Intervention Type OTHER

Basic nutrition services currently provided at the health facility and at community level in Liberia

Interventions

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Iron and folic acid (IFA) supplementation

Weekly IFA supplementation for duration of the study.

Intervention Type DIETARY_SUPPLEMENT

Targeted nutrition education

Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)

Intervention Type BEHAVIORAL

Mebendazole Pill

One-time deworming treatment with mebendazole.

Intervention Type DRUG

Standard nutrition services

Basic nutrition services currently provided at the health facility and at community level in Liberia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adolescent girl aged 10 - 19 years at the time of enrollment
* Lives within the selected study communities in Montserrado or Margibi counties
* Caregiver/adolescent consents to participate in the study

Exclusion Criteria

* Currently pregnant
* Active malaria infection as defined by positive rapid diagnostic test (RDT)
* Severe acute malnutrition at the time of enrollment
* Known malignancy
* Known sickle cell disease
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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UNICEF

OTHER

Sponsor Role collaborator

Ministry of Health, Liberia

OTHER

Sponsor Role collaborator

Liberia Institute of Statistics and Geo-Information Services

UNKNOWN

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julia Rubin-Smith

Global Health Faculty/Assistant in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia Rubin-Smith, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Other Identifiers

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P00036604

Identifier Type: -

Identifier Source: org_study_id