Acceptability and Nutritional Impact of Double-fortified Salt Containing Iodine and Folic Acid - Phase 1
DFS-IoFA-1
Evaluation of the Acceptability and Nutritional Impact of Double-fortified Salt Containing Folic Acid and Iodine Among Ethiopian Women of Reproductive Age - Assessment of Women's Nutritional Status and Salt Intakes in the Study Communities
1 other identifier
observational
100
1 country
1
Brief Summary
The overarching objective of this two-phase project is to assess the effects of fortifying iodized salt with folic acid on improving women's folate status and thereby reduce the risk of neural tube defects (NTDs), which are highly prevalent in Ethiopia. The project will be conducted in two phases. The purpose of Phase 1, described herein, is to complete formative research in preparation for a community-based, randomized trial, which will be carried out in Phase 2. The objectives of Phase 1 are to: 1) assess the hematological condition and nutritional status with respect to folate, iodine, and other micronutrients among non-pregnant women of reproductive age (WRA) in the study communities, and 2) measure discretionary salt and dietary folate intakes of the women and their households.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 31, 2023
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedMarch 13, 2025
March 1, 2025
2 months
March 3, 2023
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Folate status
Red blood cell (RBC) folate concentration using a microbiological assay
one week
Iodine status
24-hour urinary iodine excretion using the Sandell-Kolthoff color reaction
four weeks
Discretionary salt intake
In-home weighed record of dietary intake
four weeks
Household salt utilization
One-week difference in weight of salt provided by study team
six weeks
Study Arms (1)
Women of reproductive age
Randomly selected women of reproductive age in study communities.
Eligibility Criteria
The study will be conducted in the central highlands of Oromia region in Ethiopia, approximately 2 hours from the capital Addis Ababa.
You may qualify if:
- Non-pregnant women 18-49 years of age
- Agree to use salt provided by the study team for the household salt disappearance study
- Provide written, informed consent.
You may not qualify if:
- Currently pregnant
- Presence of acute or chronic disease (such as diarrhea, febrile illness, or underlying metabolic disorder) that might affect the participant's dietary intake or folate status
- Currently using medicines (like anticonvulsants and cancer treatments) that affect folate metabolism
- Medically prescribed restriction of salt intake
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- Ethiopian Public Health Institutecollaborator
- University of California, San Franciscocollaborator
- Nutrition Internationalcollaborator
Study Sites (1)
Ethiopian Public Health Institute
Addis Ababa, Ethiopia
Related Publications (1)
Agbemafle I, Woldeyohannes M, Tessema M, Fereja M, Arnold CD, Banjaw BT, Hussen A, Kebebe T, Goh YE, Arabi M, Martinez H, McDonald CM, Brown KH. Assessment of Women's Discretionary Salt Intake and Household Salt Utilization in Preparation for a Salt Fortification Trial in Oromia Region, Ethiopia. Matern Child Nutr. 2025 Apr;21(2):e13768. doi: 10.1111/mcn.13768. Epub 2024 Dec 13.
PMID: 39673143RESULT
Biospecimen
Samples of whole blood, serum, and 24-hour urine excretion will be collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth H Brown, MD
University of California, Davis
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 31, 2023
Study Start
June 26, 2023
Primary Completion
August 15, 2023
Study Completion
May 1, 2024
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The study protocol will be submitted for publication prior to initiation of Phase 2. The statistical analysis plans for Phases 1 and 2 will be publicly available prior to the start of the respective analyses. The informed consent documents will be available (in English and Afaan Oromo) after approval by the respective institutional Review Boards (IRBs) at the University of California Davis (UC Davis) and the Ethiopian Public Health Institute (EPHI). The clinical study report will become available once accepted for publication.
- Access Criteria
- As indicated above.
Two years after completion of the data collection, the individual participant data (IPD) data sets will become publicly available to other investigators who have specific research questions that can be addressed by the data and that are not already under analysis by the core research team. Researchers who desire to have access to the clinical specimens will be requested to apply for the specimens and to describe the research question(s) they plan to address.