Neural Tube Defects Clinical Trial
— FASALTOfficial title:
Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
Verified date | July 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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* Note: There are 34 references in all — Click here to view all references
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 |
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