Clinical trial NCT06734611: Folic Acid Salt Study (FISFA Zambia)
Official title: Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Folate Deficiency
Neural Tube Defects
Keywords: folic acid
iodine
salt
serum folate
red blood cell folate
prevention
folate insufficiency
Malnutrition
Nervous System Malformations
Spinal Dysraphism
Vitamin B9
Micronutrients
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
name: Baylor College of Medicine
First posted: 2024-12-16
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)
timeFrame: 0-6 months
measure: Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint)
timeFrame: 0-6 months
Secondary outcomes:
measure: Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)
timeFrame: 1,3,6 months
measure: Measure of folate insufficiency via serum and RBC concentration
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia
Study officials:
affiliation: University of Alabama at Birmingham
name: Anastasia A Smith, DrPH
role: PRINCIPAL_INVESTIGATOR
References: