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Acceptability and Nutritional Impact of Double-fortified Salt Containing Iodine and Folic Acid - Phase 1

NCT05792241 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • Folate Deficiency
  • Iodine Deficiency
  • Anemia, Macrocytic
  • Anemia Deficiency
  • Salt Intake

Sponsors & Collaborators

  • Ethiopian Public Health Institute

    collaborator OTHER_GOV

  • University of California, San Francisco

    collaborator OTHER

  • Nutrition International

    collaborator OTHER

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Kenneth H Brown, MD · University of California, Davis

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2023-08-15
Completion
2024-05-01

Countries

  • Ethiopia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05792241 on ClinicalTrials.gov