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

NCT05935631 | Completed

• 1 other identifier: 300009522
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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%.

Conditions

Neural Tube Defects; Folic Acid Deficiency; Fortification

Keywords

Serum folate

Outcome Measures

Primary Outcomes (1)

• Serum blood folate levels

  Change in serum blood folate levels from baseline to one month

  One month

Secondary Outcomes (5)

• Number of participants who are enrolled in the study

  one month

• Change in weight of salt shakers (in grams)

  one month

• Percent of participants who completed all study visits

  one month

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

  one month

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

  one month

Study Arms (1)

Salt with folic acid and iodine

EXPERIMENTAL

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.

Dietary Supplement: Salt with folic acid and iodine

Interventions

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

Salt with folic acid and iodine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: We are focusing on women specifically as we looking at maternal blood folate levels prior to potential pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women
• consumes salt

You may not qualify if:

• pregnant or intends to become pregnant in next 6 months

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (34)

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MeSH Terms

Conditions

Neural Tube Defects; Folic Acid Deficiency

Interventions

Salts; Folic Acid; Iodine

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Halogens; Elements

Study Officials

• Anastasia Arynchyna-Smith, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Manager/ DrPH student

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 7, 2023
• Study Start: January 24, 2023
• Primary Completion: April 18, 2023
• Study Completion: June 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (1)