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

Neural Tube Defects Clinical Trial

— FASALT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05935631
• Other study ID #: 300009522
• Status: Completed
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 30, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• women

• consumes salt

Exclusion Criteria:

• pregnant or intends to become pregnant in next 6 months

Related Conditions & MeSH terms

• Folic Acid Deficiency
• Fortification
• Neural Tube Defects
• Spinal Dysraphism

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (34)

Allen 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. — View Citation

Blencowe 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. — View Citation

Chen MY, Rose CE, Qi YP, Williams JL, Yeung LF, Berry RJ, Hao L, Cannon MJ, Crider KS. Defining the plasma folate concentration associated with the red blood cell folate concentration threshold for optimal neural tube defects prevention: a population-based, randomized trial of folic acid supplementation. Am J Clin Nutr. 2019 May 1;109(5):1452-1461. doi: 10.1093/ajcn/nqz027. — View Citation

Crider 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. — View Citation

Eldridge C, Bandlamuri S, Andrews JG, Galindo MK, Contreras D, Flood TJ, Rice S. Postfolate spina bifida lesion level change. Birth Defects Res. 2018 Jul 3;110(11):949-955. doi: 10.1002/bdr2.1221. Epub 2018 Mar 25. — View Citation

Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239. — View Citation

Estevez-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. — View Citation

Exchange GFD. Dashboard: Country Fortification. 2022. https://fortificationdata.org/country-fortification-dashboard/?alpha3_code=USA&lang=en

Fan 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. — View Citation

Grosse SD, Berry RJ, Mick Tilford J, Kucik JE, Waitzman NJ. Retrospective Assessment of Cost Savings From Prevention: Folic Acid Fortification and Spina Bifida in the U.S. Am J Prev Med. 2016 May;50(5 Suppl 1):S74-S80. doi: 10.1016/j.amepre.2015.10.012. Epub 2016 Jan 11. — View Citation

Hopson B, Shamblin I, Zimmerman K, Rocque B, Salehani A, Blount JP. Scope of care in the first four years of life for individuals born with myelomeningocele: A single institution experience1. J Pediatr Rehabil Med. 2021;14(4):667-673. doi: 10.3233/PRM-200803. — View Citation

Hopson 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. — View Citation

Kancherla 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. — View Citation

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. — View Citation

Kancherla 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. — View Citation

Li YO, Diosady LL, Wesley AS. Folic acid fortification through existing fortified foods: iodized salt and vitamin A-fortified sugar. Food Nutr Bull. 2011 Mar;32(1):35-41. doi: 10.1177/156482651103200104. — View Citation

Liu 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. — View Citation

Lynberg 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. — View Citation

Mai CT, Evans J, Alverson CJ, Yue X, Flood T, Arnold K, Nestoridi E, Denson L, Adisa O, Moore CA, Nance A, Zielke K, Rice S, Shan X, Dean JH, Ethen M, Hansen B, Isenburg J, Kirby RS. Changes in Spina Bifida Lesion Level after Folic Acid Fortification in the US. J Pediatr. 2022 Oct;249:59-66.e1. doi: 10.1016/j.jpeds.2022.06.023. Epub 2022 Jun 27. — View Citation

Mai CT, Isenburg J, Langlois PH, Alverson CJ, Gilboa SM, Rickard R, Canfield MA, Anjohrin SB, Lupo PJ, Jackson DR, Stallings EB, Scheuerle AE, Kirby RS; National Birth Defects Prevention Network. Population-based birth defects data in the United States, 2008 to 2012: Presentation of state-specific data and descriptive brief on variability of prevalence. Birth Defects Res A Clin Mol Teratol. 2015 Nov;103(11):972-93. doi: 10.1002/bdra.23461. No abstract available. — View Citation

McDowell MA, Lacher DA, Pfeiffer CM, Mulinare J, Picciano MF, Rader JI, Yetley EA, Kennedy-Stephenson J, Johnson CL. Blood folate levels: the latest NHANES results. NCHS Data Brief. 2008 May;(6):1-8. — View Citation

McGee EJT, Sangakkara AR, Diosady LL. Double fortification of salt with folic acid and iodine. Journal of Food Engineering. 2017/04/01/ 2017;198:72-80. doi:https://doi.org/10.1016/j.jfoodeng.2016.11.019

Modupe O, Krishnaswamy K, Diosady LL. Technology for Triple Fortification of Salt with Folic Acid, Iron, and Iodine. J Food Sci. 2019 Sep;84(9):2499-2506. doi: 10.1111/1750-3841.14730. Epub 2019 Aug 8. — View Citation

Modupe O, Siddiqui J, Jonnalagadda A, Diosady LL. Folic acid fortification of double fortified salt. Sci Rep. 2021 Jul 15;11(1):14561. doi: 10.1038/s41598-021-93194-9. — View Citation

Mokhort 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

Oumer 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. — View Citation

Pfeiffer CM, Sternberg MR, Zhang M, Fazili Z, Storandt RJ, Crider KS, Yamini S, Gahche JJ, Juan W, Wang CY, Potischman N, Williams J, LaVoie DJ. Folate status in the US population 20 y after the introduction of folic acid fortification. Am J Clin Nutr. 2019 Nov 1;110(5):1088-1097. doi: 10.1093/ajcn/nqz184. — View Citation

Powles J, Fahimi S, Micha R, Khatibzadeh S, Shi P, Ezzati M, Engell RE, Lim SS, Danaei G, Mozaffarian D; Global Burden of Diseases Nutrition and Chronic Diseases Expert Group (NutriCoDE). Global, regional and national sodium intakes in 1990 and 2010: a systematic analysis of 24 h urinary sodium excretion and dietary surveys worldwide. BMJ Open. 2013 Dec 23;3(12):e003733. doi: 10.1136/bmjopen-2013-003733. — View Citation

Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. MRC Vitamin Study Research Group. Lancet. 1991 Jul 20;338(8760):131-7. — View Citation

Puri S, Rekhi TK, Thomas T, Jadhav MH, Mannar V, Diosady LL. Sensory Trial of Quintuple Fortified Salt-Salt Fortified With Iodine, Iron, Folic Acid, Vitamin B12, and Zinc-Among Consumers in New Delhi, India. Food Nutr Bull. 2022 Sep;43(3):340-350. doi: 10.1177/03795721221078361. Epub 2022 May 8. — View Citation

Rocque BG, Bishop ER, Scogin MA, Hopson BD, Arynchyna AA, Boddiford CJ, Shannon CN, Blount JP. Assessing health-related quality of life in children with spina bifida. J Neurosurg Pediatr. 2015 Feb;15(2):144-9. doi: 10.3171/2014.10.PEDS1441. Epub 2014 Nov 21. — View Citation

Wang 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. — View Citation

Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, Hennekens CH, Speizer FE. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985 Jul;122(1):51-65. doi: 10.1093/oxfordjournals.aje.a114086. — View Citation

Williams 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. — View Citation

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum blood folate levels	Change in serum blood folate levels from baseline to one month	One month
Secondary	Number of participants who are enrolled in the study	Feasibility of enrollment: number of participants who are enrolled in the study	one month
Secondary	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.	one month
Secondary	Percent of participants who completed all study visits	Percent of participants who completed all study visits	one month
Secondary	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)	one month
Secondary	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)	one month