Nutritional AnemiaNCT05073562
Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia
A study testing Iron and folic acid (IFA) supplementation, Targeted nutrition education and Mebendazole Pill in people with Nutritional Anemia and Nutritional Deficiency, run by Boston Children's Hospital.
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… Read more about this study
- Who is it for?
- Ages 10 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional Anemia, Nutritional Deficiency, Iron Deficiency Anemia Treatment
- What is being tested?
- Iron and folic acid (IFA) supplementation, Targeted nutrition education and Mebendazole Pill
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Study on the Effectiveness of IFA Supplementation, Deworming, and Nutrition Education in Addressing Anemia Among Adolescent Girls in Two Counties in Liberia
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.
- Conditions
- Nutritional Anemia, Nutritional Deficiency, Iron Deficiency Anemia Treatment, Folic Acid Deficiency Anemia, Dietary, Adolescent Development, Knowledge, Attitudes, Practice
- Being tested
- Iron and folic acid (IFA) supplementation, Targeted nutrition education, Mebendazole Pill, Standard nutrition services
- Medical subject headings
- Malnutrition, Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron and folic acid (IFA) supplementationDietary supplement
Weekly IFA supplementation for duration of the study.
Targeted nutrition educationBehavioural
Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)
Mebendazole PillDrug
One-time deworming treatment with mebendazole.
Standard nutrition servicesOther
Basic nutrition services currently provided at the health facility and at community level in Liberia
| Study group | Role | What they receive |
|---|---|---|
| Nutrition+ Intervention | Experimental | 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. Receives: Dietary Supplement: Iron and folic acid (IFA) supplementation; Behavioral: Targeted nutrition education; Drug: Mebendazole Pill |
| Control group - standard services only | Active comparator | 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. Receives: Other: Standard nutrition services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (2)
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.
Measured: Baseline and Week 12
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Change in funding availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional AnemiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, Ministry of Health, Liberia, Liberia Institute of Statistics and Geo-Information Services
- Responsible party
- Principal investigator, Julia Rubin-Smith, Boston Children's Hospital
- Investigators
- Julia Rubin-Smith, MD, MSPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073562
- Sponsor's protocol ID
- P00036604
- Status last verified
- Nov 2021
- First submitted
- 1 Aug 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effectiveness of IFA Supplementation, Deworming, and Nutrition Education in Addressing Anemia Among Adolescent Girls in Two Counties in Liberia
- ClinicalTrials.gov ID
- NCT05073562
- Acronym / sponsor ID
- P00036604
- Conditions
- Nutritional Anemia, Nutritional Deficiency, Iron Deficiency Anemia Treatment, Folic Acid Deficiency Anemia, Dietary, Adolescent Development, Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in funding availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- UNICEF, Ministry of Health, Liberia, Liberia Institute of Statistics and Geo-Information Services
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition+ Intervention | Experimental | Dietary Supplement: Iron and folic acid (IFA) supplementation, Behavioral: Targeted nutrition education, Drug: Mebendazole PillThis 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. |
| Control group - standard services only | Active comparator | Other: Standard nutrition servicesThis 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron and folic acid (IFA) supplementationWeekly IFA supplementation for duration of the study. | Dietary supplement | Nutrition+ Intervention |
| Targeted nutrition educationStructured nutrition education package delivered at household level by trained Community Health Assistants (CHAs) | Behavioural | Nutrition+ Intervention |
| Mebendazole PillOne-time deworming treatment with mebendazole. | Drug | Nutrition+ Intervention |
| Standard nutrition servicesBasic nutrition services currently provided at the health facility and at community level in Liberia | Other | Control group - standard services only |
Primary outcome
Change in participants' hemoglobin level from enrollment to completion of the study
Time frame: Baseline and Week 12
Point of care hemoglobin testing will be conducted at enrollment and at the conclusion of the study.
2 secondary outcomes
Changes in responses to questions in the Nutrition Knowledge, Attitudes, and Practice (KAP) survey from baseline to follow up evaluation
Time frame: Baseline and Week 12
Feasibility of targeted intervention for scale-up to country-wide enhanced nutrition services
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Rubin-Smith, MD, MSPH principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Iron and folic acid (IFA) supplementation, Targeted nutrition education and Mebendazole Pill in people with Nutritional Anemia and Nutritional Deficiency, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participants' hemoglobin level from enrollment to completion of the study (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.