Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
NCT ID: NCT05935631
Last Updated: 2023-08-01
Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2023-01-24
2023-06-30
Brief Summary
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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%.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* consumes salt
Exclusion Criteria
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Anastasia Arynchyna
Clinical Research Manager/ DrPH student
Principal Investigators
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Anastasia Arynchyna-Smith, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Other Identifiers
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300009522
Identifier Type: -
Identifier Source: org_study_id
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