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

Neural Tube Defects Clinical Trial

— FASALT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05935631
• Other study ID #: 300009522
• Status: Completed
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 30, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• women
• consumes salt

Exclusion Criteria:

• pregnant or intends to become pregnant in next 6 months

Related Conditions & MeSH terms

• Folic Acid Deficiency
• Fortification
• Neural Tube Defects
• Spinal Dysraphism

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum blood folate levels	Change in serum blood folate levels from baseline to one month	One month
Secondary	Number of participants who are enrolled in the study	Feasibility of enrollment: number of participants who are enrolled in the study	one month
Secondary	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.	one month
Secondary	Percent of participants who completed all study visits	Percent of participants who completed all study visits	one month
Secondary	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)	one month
Secondary	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)	one month