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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05073562
Other study ID # P00036604
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date December 2021

Study information

Verified date November 2021
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 19 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Iron and folic acid (IFA) supplementation
Weekly IFA supplementation for duration of the study.
Behavioral:
Targeted nutrition education
Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)
Drug:
Mebendazole Pill
One-time deworming treatment with mebendazole.
Other:
Standard nutrition services
Basic nutrition services currently provided at the health facility and at community level in Liberia

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Boston Children's Hospital Liberia Institute of Statistics and Geo-Information Services, Ministry of Health, Liberia, UNICEF

Outcome

Type Measure Description Time frame Safety issue
Primary Change in participants' hemoglobin level from enrollment to completion of the study Point of care hemoglobin testing will be conducted at enrollment and at the conclusion of the study. Baseline and Week 12
Secondary Changes in responses to questions in the Nutrition Knowledge, Attitudes, and Practice (KAP) survey from baseline to follow up evaluation Increase in nutrition-related knowledge, and improvements in nutrition practices as evidenced by changes in responses to the KAP survey, which is based on validated measures of nutrition-related knowledge, attitudes, and practices, and has been modified for appropriateness to the target population of this study. Baseline and Week 12
Secondary Feasibility of targeted intervention for scale-up to country-wide enhanced nutrition services Successful completion of study visits by Community Health Assistants, specifically ability to conduct every scheduled visit without skipping visits or households, within the timeframe of scheduled work day. 12 weeks
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