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

Primary Purpose

Neural Tube Defects, Folic Acid Deficiency, Fortification

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Salt with folic acid and iodine
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neural Tube Defects focused on measuring Serum folate

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: women consumes salt Exclusion Criteria: pregnant or intends to become pregnant in next 6 months

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Salt with folic acid and iodine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants who are enrolled in the study
Feasibility of enrollment: number of participants who are enrolled in the study
Change in weight of salt shakers (in grams)
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
Percent of participants who completed all study visits
Measure of effect salt with folic acid had on taste of food using Likert scale
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
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)

Full Information

First Posted
June 16, 2023
Last Updated
July 31, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05935631
Brief Title
Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
Acronym
FASALT
Official Title
Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
April 18, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neural Tube Defects, Folic Acid Deficiency, Fortification
Keywords
Serum folate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salt with folic acid and iodine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Salt with folic acid and iodine
Intervention Description
Assess serum and RBC folate levels in women at baseline and 1 month after ingesting salt with folic acid
Primary Outcome Measure Information:
Title
Serum blood folate levels
Description
Change in serum blood folate levels from baseline to one month
Time Frame
One month
Secondary Outcome Measure Information:
Title
Number of participants who are enrolled in the study
Description
Feasibility of enrollment: number of participants who are enrolled in the study
Time Frame
one month
Title
Change in weight of salt shakers (in grams)
Description
Acceptability of salt with folic acid and iodine by the participants through weighting salt shackers before and after and calculating amount of salt ingested.
Time Frame
one month
Title
Percent of participants who completed all study visits
Description
Percent of participants who completed all study visits
Time Frame
one month
Title
Measure of effect salt with folic acid had on taste of food using Likert scale
Description
Did using this salt negatively affect the taste of your food overall? It is measured on Likert scale (1- strongly disagree, 5 strongly agree)
Time Frame
one month
Title
Measure of whether the color of salt negatively affect their desire to use it daily using Likert Scale
Description
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)
Time Frame
one month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
We are focusing on women specifically as we looking at maternal blood folate levels prior to potential pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women consumes salt Exclusion Criteria: pregnant or intends to become pregnant in next 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasia Arynchyna-Smith, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
If another investigator has a valid research question and hypothesis that fits in with the study sample, we will consider sharing de-identified dataset. Participants have consented to share their de-identified data with future researchers.
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Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study

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