Clinical trial NCT05935631: Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
Official title: Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neural Tube Defects
Folic Acid Deficiency
Fortification
Keywords: Serum folate
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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%.


Eligibility criteria: Inclusion Criteria:

* women
* consumes salt

Exclusion Criteria:

* pregnant or intends to become pregnant in next 6 months

Primary outcomes:
measure: Serum blood folate levels
timeFrame: One month
Secondary outcomes:
measure: Number of participants who are enrolled in the study
timeFrame: one month
measure: Change in weight of salt shakers (in grams)
timeFrame: one month
measure: Percent of participants who completed all study visits
timeFrame: one month
measure: Measure of effect salt with folic acid had on taste of food using Likert scale
timeFrame: one month
measure: Measure of whether the color of salt negatively affect their desire to use it daily using Likert Scale
timeFrame: one month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Anastasia Arynchyna-Smith, MPH
role: PRINCIPAL_INVESTIGATOR
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