Folic Acid Deficiency, Fortification, Neural Tube Defects
Conditions
Keywords
Serum folate
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%.
Interventions
DIETARY_SUPPLEMENTSalt with folic acid and iodine
Assess serum and RBC folate levels in women at baseline and 1 month after ingesting salt with folic acid
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* women * consumes salt
Exclusion criteria
* pregnant or intends to become pregnant in next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum blood folate levels | One month | Change in serum blood folate levels from baseline to one month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who are enrolled in the study | one month | Feasibility of enrollment: number of participants who are enrolled in the study |
| Change in weight of salt shakers (in grams) | one month | 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 | one month | Percent of participants who completed all study visits |
| Measure of effect salt with folic acid had on taste of food using Likert scale | one month | 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 | one month | 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) |
Countries
United States
Outcome results
None listed