FASALT: Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05935631

Collaborator

(none)

Enrollment

Location

Arm

5.2

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim 1: Assess directional signal of effect of fortified salt with folic acid and iodine on blood serum folate levels.

It will be accomplished by feasibility pre-test/post-test clinical study by estimating mean and variability of serum blood folate levels effects of folic acid fortified salt.

Hypothesis: Fortified salt with folic acid and iodine will increase serum blood folate levels from baseline by month 1.

Aim 2: Assess feasibility and acceptability of salt fortified with folic acid and iodine.

Feasibility will be measured by 1) subjects' refusal rate of consent by 30 subjects during 6-month enrollment period; 2) method of determining salt consumption (weighting the saltshaker pre and post); 3) completion rates of study protocols from baseline to follow up. Hypothesis 1a: Completion of all blood draw visits will be 90-100%.

Acceptability will be measured by 1) completion rate of daily salt logs; 2) consumption of salt by weighting saltshakers; 3) attitude towards taste and color difference. Hypothesis 1b: Completion rate (90-100%) of daily salt logs will range from 90-100% of participants and 2) consumption of salt will range from 90-100% of participants.

Dietary surveys will be employed to document dietary habits and estimated daily FA intake in the sample population. Feasibility and acceptability of dietary surveys will be measured by willingness to answer survey questions. Hypothesis 1c: Completion rate of dietary surveys will range 90-100%.

Condition or Disease	Intervention/Treatment	Phase
Neural Tube Defects Folic Acid Deficiency Fortification	Dietary Supplement: Salt with folic acid and iodine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pre-test and post-test of serum folate levels after using salt with folic acid in the same group of women, each serving as their own control.Pre-test and post-test of serum folate levels after using salt with folic acid in the same group of women, each serving as their own control.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study

Actual Study Start Date :

Jan 24, 2023

Actual Primary Completion Date :

Apr 18, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Salt with folic acid and iodine Intervention is intake of double fortified salt with folic acid and iodine (DFS). We will ask the participants to substitute their current salt with the study saltshaker and use it when preparing food or when eating out. We estimate minimum daily intake from salt consumption by participants will be 200 micrograms (µg) of folic acid per serving. Serving is 2g of salt. Participants will be given portion suggestions: 1/2 teaspoon or 2-3 pinches or 8-10 shakes/5 times a day. Containers (125g) will be weighted at the beginning and end of 1 month. We will ask each day if woman cooked/used the salt for herself only or to list number of people each day. Participants will also agree to complete either daily paper salt log. A commercially available salt that is fortified with folic acid has been provided by AlpenJodSalz produced by Sudwestdeutsche Salzwerk. For 30 participants, we will need 30 containers.	Dietary Supplement: Salt with folic acid and iodine Assess serum and RBC folate levels in women at baseline and 1 month after ingesting salt with folic acid

Arm

Intervention/Treatment

Experimental: Salt with folic acid and iodine

Intervention is intake of double fortified salt with folic acid and iodine (DFS). We will ask the participants to substitute their current salt with the study saltshaker and use it when preparing food or when eating out. We estimate minimum daily intake from salt consumption by participants will be 200 micrograms (µg) of folic acid per serving. Serving is 2g of salt. Participants will be given portion suggestions: 1/2 teaspoon or 2-3 pinches or 8-10 shakes/5 times a day. Containers (125g) will be weighted at the beginning and end of 1 month. We will ask each day if woman cooked/used the salt for herself only or to list number of people each day. Participants will also agree to complete either daily paper salt log. A commercially available salt that is fortified with folic acid has been provided by AlpenJodSalz produced by Sudwestdeutsche Salzwerk. For 30 participants, we will need 30 containers.

Dietary Supplement: Salt with folic acid and iodine

Assess serum and RBC folate levels in women at baseline and 1 month after ingesting salt with folic acid

Outcome Measures

Primary Outcome Measures

Serum blood folate levels [One month]
Change in serum blood folate levels from baseline to one month

Secondary Outcome Measures

Number of participants who are enrolled in the study [one month]
Feasibility of enrollment: number of participants who are enrolled in the study
Change in weight of salt shakers (in grams) [one month]
Acceptability of salt with folic acid and iodine by the participants through weighting salt shackers before and after and calculating amount of salt ingested.
Percent of participants who completed all study visits [one month]
Percent of participants who completed all study visits
Measure of effect salt with folic acid had on taste of food using Likert scale [one month]
Did using this salt negatively affect the taste of your food overall? It is measured on Likert scale (1- strongly disagree, 5 strongly agree)
Measure of whether the color of salt negatively affect their desire to use it daily using Likert Scale [one month]
Did the color of salt negatively affect your desire to use it daily? It is measured on Likert scale (1- strongly disagree, 5 strongly agree)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

women
consumes salt

Exclusion Criteria:

pregnant or intends to become pregnant in next 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Anastasia Arynchyna-Smith, MPH, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Anastasia Arynchyna, Clinical Research Manager/ DrPH student, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT05935631

Other Study ID Numbers:

300009522

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Anastasia Arynchyna, Clinical Research Manager/ DrPH student, University of Alabama at Birmingham

Serum folate

Additional relevant MeSH terms:

Neural Tube Defects

Spinal Dysraphism

Folic Acid Deficiency

Folic Acid

Study Results

No Results Posted as of Jul 7, 2023