Skip to main content
OpenTrials
Completed

NCT Number: NCT05935631

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

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%.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neural Tube Defects Avitaminosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Folic Acid Deficiency Fortification Malnutrition Nervous System Diseases Nervous System Malformations Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B Deficiency

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women
  • consumes salt

Exclusion criteria

  • pregnant or intends to become pregnant in next 6 months

Treatment and study plan

Salt with folic acid and iodine

Dietary Supplement

Assess serum and RBC folate levels in women at baseline and 1 month after ingesting salt with folic acid

Primary outcomes

  1. Serum blood folate levels

    Time frame: One month

    Change in serum blood folate levels from baseline to one month

Secondary outcomes

  1. Number of participants who are enrolled in the study

    Time frame: one month

    Feasibility of enrollment: number of participants who are enrolled in the study

  2. Change in weight of salt shakers (in grams)

    Time frame: 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.

  3. Percent of participants who completed all study visits

    Time frame: one month

    Percent of participants who completed all study visits

  4. Measure of effect salt with folic acid had on taste of food using Likert scale

    Time frame: 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)

  5. Measure of whether the color of salt negatively affect their desire to use it daily using Likert Scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: FASALT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.