Clinical trial NCT05935631 - References

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

Citation(s)

•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.

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

Details for clinical trial NCT05935631