Folic Acid Salt Study (FISFA Zambia)

The University of Alabama at Birmingham

Status

Begins enrollment this month

Conditions

Neural Tube Defects

Folate Deficiency

Treatments

Dietary Supplement: Fortified Iodized Salt with Folic Acid (FISFA)

Study type

Interventional

Funder types

Other

Identifiers

NCT06734611

IRB-300013997

FISFA-Zambia-2025 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

250 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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