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

NCT05935631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-08-01

No results posted yet for this study

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%.

Conditions

  • Neural Tube Defects
  • Folic Acid Deficiency
  • Fortification

Interventions

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Anastasia Arynchyna-Smith, MPH · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-24
Primary Completion
2023-04-18
Completion
2023-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935631 on ClinicalTrials.gov