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NCT Number: NCT06734611

Folic Acid Salt Study (FISFA Zambia)

Question: How effective is fortified iodized salt with folic acid (FISFA) in increasing serum and red blood cell folate in non-lactating, non-pregnant women of reproductive age in the country of Zambia who do not have active food fortification with a folic acid program?

Participants will:

* Consume salt with folic acid instead of their regular salt for 6 months * Have a blood draw 4 times * Fill out surveys

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Key information

Conditions

Folate Deficiency Avitaminosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Folic Acid Deficiency Malnutrition Nervous System Diseases Nervous System Malformations Neural Tube Defects Nutrition Disorders Nutritional and Metabolic Diseases Spinal Dysraphism Vitamin B Deficiency

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

The objective of this nonrandomized controlled intervention trial is to measure the effectiveness of fortified iodized salt with folic acid (FISFA) on increasing blood folate concentrations as a preventive measure against folate-sensitive neural tube defects (NTDs) in a non-fortifying country of Zambia.

The main questions it aims to answer are:

Aim 1: Measure the effectiveness of FISFA on increasing serum and red blood cell folate concentrations in women of reproductive age in a non-fortifying country.

Aim 2: Assess the risk of neural tube defects by measuring folate insufficiency levels via serum and red blood cell concentrations in women of reproductive age in a non-fortifying country.

Aim 3: Assess taste and color acceptability of FISFA by study population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation in the study
  • Do not intend to get pregnant
  • Not lactating or pregnant
  • Live alone or with a partner if they can be compliant and not share the study salt.
  • Aged between 18 and 45 years

Exclusion criteria

  • Pregnant or lactating

Treatment and study plan

Fortified Iodized Salt with Folic Acid (FISFA)

Dietary Supplement

Addition of folic acid to iodized salt for daily consumption to assess folate levels.

Primary outcomes

  1. Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)

    Time frame: 0-6 months

    Evaluate folate blood levels pre and post intervention

  2. Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint)

    Time frame: 0-6 months

    Evaluate folate blood levels pre and post intervention

Secondary outcomes

  1. Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)

    Time frame: 1,3,6 months

    Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome)

  2. Measure of folate insufficiency via serum and RBC concentration

    Time frame: 0-6 months

    Comparing folate insufficiency via serum and RBC concentration to recommended levels of 25.5 nmol/L (serum) and 906 nmol/L in RBC for WRA

Study contacts

Contact information is provided by the study sponsor or research team.

Anastasia A Smith, DrPH

CONTACT

[email protected]

205-276-1067

Anna Munger, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Baylor College of Medicine
  • Centre for Infectious Disease Research in Zambia

Registry information

Official study title

Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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