Neural Tube DefectsFASALTNCT05935631
Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
A study testing Salt with folic acid and iodine in people with Neural Tube Defects and Folic Acid Deficiency, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neural Tube Defects, Folic Acid Deficiency, Fortification
- What is being tested?
- Salt with folic acid and iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- consumes salt
Who cannot join
- pregnant or intends to become pregnant in next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this 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.
Read more
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
- Being tested
- Salt with folic acid and iodine
- Keywords
- Serum folate
- Medical subject headings
- Neural Tube Defects, Folic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt with folic acid and iodineDietary supplement
Assess serum and RBC folate levels in women at baseline and 1 month after ingesting salt with folic acid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Salt with folic acid and iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum blood folate levels
Change in serum blood folate levels from baseline to one month
Measured: One month
Secondary outcomes (5)
Number of participants who are enrolled in the study
Feasibility of enrollment: number of participants who are enrolled in the study
Measured: one month
Change in weight of salt shakers (in grams)
Acceptability of salt with folic acid and iodine by the participants through weighting salt shackers before and after and calculating amount of salt ingested.
Measured: one month
Percent of participants who completed all study visits
Percent of participants who completed all study visits
Measured: one month
Measure of effect salt with folic acid had on taste of food using Likert scale
Did using this salt negatively affect the taste of your food overall? It is measured on Likert scale (1- strongly disagree, 5 strongly agree)
Measured: one month
Measure of whether the color of salt negatively affect their desire to use it daily using Likert Scale
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)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start24 Jan 2023
- Primary completion18 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia Arynchyna, University of Alabama at Birmingham
- Investigators
- Anastasia Arynchyna-Smith, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935631
- Sponsor's protocol ID
- 300009522
- Acronym
- FASALT
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If another investigator has a valid research question and hypothesis that fits in with the study sample, we will consider sharing de-identified dataset. Participants have consented to share their de-identified data with future researchers.
Publications
Kancherla V, Wagh K, Pachon H, Oakley GP Jr. A 2019 global update on folic acid-preventable spina bifida and anencephaly. Birth Defects Res. 2021 Jan 1;113(1):77-89. doi: 10.1002/bdr2.1835. Epub 2020 Oct 30.
PubMed 33124747Kancherla V, Tsang B, Wagh K, Dixon M, Oakley GP Jr. Modeling shows high potential of folic acid-fortified salt to accelerate global prevention of major neural tube defects. Birth Defects Res. 2020 Nov;112(18):1461-1474. doi: 10.1002/bdr2.1769. Epub 2020 Aug 1.
PubMed 32738033Blencowe H, Kancherla V, Moorthie S, Darlison MW, Modell B. Estimates of global and regional prevalence of neural tube defects for 2015: a systematic analysis. Ann N Y Acad Sci. 2018 Feb;1414(1):31-46. doi: 10.1111/nyas.13548. Epub 2018 Jan 24.
PubMed 29363759Allen R, James A, Sankaran S. Trends in termination of pregnancy for neural tube defects in England and Wales from 2007 to 2017: Observational prospective study. Prenat Diagn. 2021 Dec;41(13):1624-1633. doi: 10.1002/pd.6060. Epub 2021 Oct 26.
PubMed 34671992Lynberg MC, Khoury MJ. Contribution of birth defects to infant mortality among racial/ethnic minority groups, United States, 1983. MMWR CDC Surveill Summ. 1990 Jul;39(3):1-12.
PubMed 2115106Hopson B; MSHA; Alford EN, Zimmerman K, Blount JP, Rocque BG. Development of an evidence-based individualized transition plan for spina bifida. Neurosurg Focus. 2019 Oct 1;47(4):E17. doi: 10.3171/2019.7.FOCUS19425.
PubMed 31574471Crider KS, Devine O, Hao L, Dowling NF, Li S, Molloy AM, Li Z, Zhu J, Berry RJ. Population red blood cell folate concentrations for prevention of neural tube defects: Bayesian model. BMJ. 2014 Jul 29;349:g4554. doi: 10.1136/bmj.g4554.
PubMed 25073783Estevez-Ordonez D, Davis MC, Hopson B; MSHA; Arynchyna A, Rocque BG, Fieggen G, Rosseau G, Oakley G; MSPM; Blount JP. Reducing inequities in preventable neural tube defects: the critical and underutilized role of neurosurgical advocacy for folate fortification. Neurosurg Focus. 2018 Oct;45(4):E20. doi: 10.3171/2018.7.FOCUS18231.
PubMed 30269587Oumer M, Tazebew A, Silamsaw M. Birth prevalence of neural tube defects and associated risk factors in Africa: a systematic review and meta-analysis. BMC Pediatr. 2021 Apr 21;21(1):190. doi: 10.1186/s12887-021-02653-9.
PubMed 33882899Williams J, Mai CT, Mulinare J, Isenburg J, Flood TJ, Ethen M, Frohnert B, Kirby RS; Centers for Disease Control and Prevention. Updated estimates of neural tube defects prevented by mandatory folic Acid fortification - United States, 1995-2011. MMWR Morb Mortal Wkly Rep. 2015 Jan 16;64(1):1-5.
PubMed 25590678Kancherla V, Wagh K, Priyadarshini P, Pachon H, Oakley GP Jr. A global update on the status of prevention of folic acid-preventable spina bifida and anencephaly in year 2020: 30-Year anniversary of gaining knowledge about folic acid's prevention potential for neural tube defects. Birth Defects Res. 2022 Dec 1;114(20):1392-1403. doi: 10.1002/bdr2.2115. Epub 2022 Nov 7.
PubMed 36345648Wang A, Rose CE, Qi YP, Williams JL, Pfeiffer CM, Crider KS. Impact of Voluntary Folic Acid Fortification of Corn Masa Flour on RBC Folate Concentrations in the U.S. (NHANES 2011-2018). Nutrients. 2021 Apr 16;13(4):1325. doi: 10.3390/nu13041325.
PubMed 33923768Fan L, Meng F, Sun Q, Zhai Y, Liu P. Assessment of Sustainable Elimination Criteria for Iodine Deficiency Disorders Recommended by International Organizations. Front Nutr. 2022 Apr 13;9:852398. doi: 10.3389/fnut.2022.852398. eCollection 2022.
PubMed 35495946Liu T, Li Y, Teng D, Shi X, Yan L, Yang J, Yao Y, Ye Z, Ba J, Chen B, Du J, He L, Lai X, Teng X, Li Y, Chi H, Liao E, Liu C, Liu L, Qin G, Qin Y, Quan H, Shi B, Sun H, Tang X, Tong N, Wang G, Zhang JA, Wang Y, Xue Y, Yang L, Zhang Q, Zhang L, Zhu J, Zhu M, Shan Z, Teng W. The Characteristics of Iodine Nutrition Status in China After 20 Years of Universal Salt Iodization: An Epidemiology Study Covering 31 Provinces. Thyroid. 2021 Dec;31(12):1858-1867. doi: 10.1089/thy.2021.0301. Epub 2021 Dec 2.
PubMed 34806437Mokhort T, Petrenko S, Leushev B, Fedorenko E, Kolomiets N, Mokhort A. Assessment of iodine status among school age children and pregnant women of Belarus in 2017-2018. Clinical and experimental thyroidology. 11/13 2018;14doi:10.14341/ket9732
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
- ClinicalTrials.gov ID
- NCT05935631
- Acronym / sponsor ID
- FASALT / 300009522
- Conditions
- Neural Tube Defects, Folic Acid Deficiency, Fortification
- Keywords
- Serum folate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Salt with folic acid and iodine | Experimental | Dietary Supplement: Salt with folic acid and iodineIntervention 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women
- consumes salt
Key exclusion criteria (1 listed)
- pregnant or intends to become pregnant in next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt with folic acid and iodineAssess serum and RBC folate levels in women at baseline and 1 month after ingesting salt with folic acid | Dietary supplement | Salt with folic acid and iodine |
Primary outcome
Serum blood folate levels
Time frame: One month
Change in serum blood folate levels from baseline to one month
5 secondary outcomes
Number of participants who are enrolled in the study
Time frame: one month
Change in weight of salt shakers (in grams)
Time frame: one month
Percent of participants who completed all study visits
Time frame: one month
Measure of effect salt with folic acid had on taste of food using Likert scale
Time frame: one month
Measure of whether the color of salt negatively affect their desire to use it daily using Likert Scale
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 33124747Kancherla V, Wagh K, Pachon H, Oakley GP Jr. A 2019 global update on folic acid-preventable spina bifida and anencephaly. Birth Defects Res. 2021 Jan 1;113(1):77-89. doi: 10.1002/bdr2.1835. Epub 2020 Oct 30.
- Background: PubMed 32738033Kancherla V, Tsang B, Wagh K, Dixon M, Oakley GP Jr. Modeling shows high potential of folic acid-fortified salt to accelerate global prevention of major neural tube defects. Birth Defects Res. 2020 Nov;112(18):1461-1474. doi: 10.1002/bdr2.1769. Epub 2020 Aug 1.
- Background: PubMed 29363759Blencowe H, Kancherla V, Moorthie S, Darlison MW, Modell B. Estimates of global and regional prevalence of neural tube defects for 2015: a systematic analysis. Ann N Y Acad Sci. 2018 Feb;1414(1):31-46. doi: 10.1111/nyas.13548. Epub 2018 Jan 24.
- Background: PubMed 34671992Allen R, James A, Sankaran S. Trends in termination of pregnancy for neural tube defects in England and Wales from 2007 to 2017: Observational prospective study. Prenat Diagn. 2021 Dec;41(13):1624-1633. doi: 10.1002/pd.6060. Epub 2021 Oct 26.
- Background: PubMed 2115106Lynberg MC, Khoury MJ. Contribution of birth defects to infant mortality among racial/ethnic minority groups, United States, 1983. MMWR CDC Surveill Summ. 1990 Jul;39(3):1-12.
- Background: PubMed 31574471Hopson B; MSHA; Alford EN, Zimmerman K, Blount JP, Rocque BG. Development of an evidence-based individualized transition plan for spina bifida. Neurosurg Focus. 2019 Oct 1;47(4):E17. doi: 10.3171/2019.7.FOCUS19425.
- Background: PubMed 25073783Crider KS, Devine O, Hao L, Dowling NF, Li S, Molloy AM, Li Z, Zhu J, Berry RJ. Population red blood cell folate concentrations for prevention of neural tube defects: Bayesian model. BMJ. 2014 Jul 29;349:g4554. doi: 10.1136/bmj.g4554.
- Background: PubMed 30269587Estevez-Ordonez D, Davis MC, Hopson B; MSHA; Arynchyna A, Rocque BG, Fieggen G, Rosseau G, Oakley G; MSPM; Blount JP. Reducing inequities in preventable neural tube defects: the critical and underutilized role of neurosurgical advocacy for folate fortification. Neurosurg Focus. 2018 Oct;45(4):E20. doi: 10.3171/2018.7.FOCUS18231.
- Background: PubMed 33882899Oumer M, Tazebew A, Silamsaw M. Birth prevalence of neural tube defects and associated risk factors in Africa: a systematic review and meta-analysis. BMC Pediatr. 2021 Apr 21;21(1):190. doi: 10.1186/s12887-021-02653-9.
- Background: PubMed 25590678Williams J, Mai CT, Mulinare J, Isenburg J, Flood TJ, Ethen M, Frohnert B, Kirby RS; Centers for Disease Control and Prevention. Updated estimates of neural tube defects prevented by mandatory folic Acid fortification - United States, 1995-2011. MMWR Morb Mortal Wkly Rep. 2015 Jan 16;64(1):1-5.
- Background: PubMed 36345648Kancherla V, Wagh K, Priyadarshini P, Pachon H, Oakley GP Jr. A global update on the status of prevention of folic acid-preventable spina bifida and anencephaly in year 2020: 30-Year anniversary of gaining knowledge about folic acid's prevention potential for neural tube defects. Birth Defects Res. 2022 Dec 1;114(20):1392-1403. doi: 10.1002/bdr2.2115. Epub 2022 Nov 7.
- Background: PubMed 33923768Wang A, Rose CE, Qi YP, Williams JL, Pfeiffer CM, Crider KS. Impact of Voluntary Folic Acid Fortification of Corn Masa Flour on RBC Folate Concentrations in the U.S. (NHANES 2011-2018). Nutrients. 2021 Apr 16;13(4):1325. doi: 10.3390/nu13041325.
- Individual participant dataSharing planned: Undecided. If another investigator has a valid research question and hypothesis that fits in with the study sample, we will consider sharing de-identified dataset. Participants have consented to share their de-identified data with future researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasia Arynchyna-Smith, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt with folic acid and iodine in people with Neural Tube Defects and Folic Acid Deficiency, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum blood folate levels (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935631, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.