[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572541":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":30,"studyPopulation":23,"armGroups":31,"interventions":38,"overallOfficials":44,"centralContacts":48,"locations":56,"responsibleParty":87,"collaborators":90,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":23,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":23,"studyType":108,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":72,"whyStopped":23,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)","Evaluate folate blood levels pre and post intervention","0-6 months",{"measure":14,"description":11,"timeFrame":12},"Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint)",[16,20],{"measure":17,"description":18,"timeFrame":19},"Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)","Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome)","1,3,6 months",{"measure":21,"description":22,"timeFrame":12},"Measure of folate insufficiency via serum and RBC concentration","Comparing folate insufficiency via serum and RBC concentration to recommended levels of 25.5 nmol\u002FL (serum) and 906 nmol\u002FL in RBC for WRA",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","PREVENTION",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE","The objective of this nonrandomized controlled intervention trial is to measure the effectiveness of fortified iodized salt with folic acid (FISFA) on increasing blood folate concentrations as a preventive measure against folate-sensitive neural tube defects (NTDs) in a non-fortifying country of Zambia.\n\nThe main questions it aims to answer are:\n\nAim 1: Measure the effectiveness of FISFA on increasing serum and red blood cell folate concentrations in women of reproductive age in a non-fortifying country.\n\nAim 2: Assess the risk of neural tube defects by measuring folate insufficiency levels via serum and red blood cell concentrations in women of reproductive age in a non-fortifying country.\n\nAim 3: Assess taste and color acceptability of FISFA by study population.",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"FISFA arm","EXPERIMENTAL","Dietary Supplement: fortified iodized salt with folic acid (FISFA)",[37],"Dietary Supplement: Fortified Iodized Salt with Folic Acid (FISFA)",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":23},"DIETARY_SUPPLEMENT","Fortified Iodized Salt with Folic Acid (FISFA)","Addition of folic acid to iodized salt for daily consumption to assess folate levels.",[33],[45],{"name":46,"affiliation":5,"role":47},"Anastasia A Smith, DrPH","PRINCIPAL_INVESTIGATOR",[49,53],{"name":46,"role":50,"phone":51,"phoneExt":23,"email":52},"CONTACT","205-276-1067","anastasia.arynchyna@childrensal.org",{"name":54,"role":50,"phone":23,"phoneExt":23,"email":55},"Anna Munger, MS","amunger@uabmc.edu",[57,70],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":23},"ACTIVE_NOT_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-86.80249,33.52066,{"lat":68,"lon":67},{"facility":71,"status":72,"city":73,"state":23,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Centre for Infectious Disease Research in Zambia","RECRUITING","Lusaka","10101","Zambia","ZM",{"type":65,"coordinates":78},[79,80],28.28713,-15.40669,{"lat":80,"lon":79},[83],{"name":84,"role":50,"phone":85,"phoneExt":23,"email":86},"Albert Manasyan, MD","+260 976 448 994","Albert.Manasyan@cidrz.org",{"type":47,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Anastasia Smith","Clinical Research Manager",[91,92],{"name":71,"class":6},{"name":93,"class":6},"Baylor College of Medicine","100572541","folic-acid-salt-study-fisfa-zambia-100572541",false,"NCT06734611","Folic Acid Salt Study (FISFA Zambia)","Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country","Inclusion Criteria:\n\n* Voluntary participation in the study\n* Do not intend to get pregnant\n* Not lactating or pregnant\n* Live alone or with a partner if they can be compliant and not share the study salt.\n* Aged between 18 and 45 years\n\nExclusion Criteria:\n\n* Pregnant or lactating",true,"FEMALE","18 Years","45 Years",{"count":106,"type":107},250,"ESTIMATED","INTERVENTIONAL",[25],"Question: How effective is fortified iodized salt with folic acid (FISFA) in increasing serum and red blood cell folate in non-lactating, non-pregnant women of reproductive age in the country of Zambia who do not have active food fortification with a folic acid program?\n\nParticipants will:\n\n* Consume salt with folic acid instead of their regular salt for 6 months\n* Have a blood draw 4 times\n* Fill out surveys",[112,113],"Folate Deficiency","Neural Tube Defects",[115,116,117,118,119,120,121,122,123,124,125,126],"folic acid","iodine","salt","serum folate","red blood cell folate","prevention","folate insufficiency","Malnutrition","Nervous System Malformations","Spinal Dysraphism","Vitamin B9","Micronutrients","2026-06-24",{"date":129,"type":130},"2026-06-29","ACTUAL",{"date":132,"type":130},"2026-04-10",{"date":134,"type":107},"2028-12-31",{"name":5,"class":6},2]