[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100386310":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":11,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":11,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":11,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":11},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Folic acid 5mg","ACTIVE_COMPARATOR",null,[13],"Dietary Supplement: Folic acid",{"label":15,"type":10,"description":11,"interventionNames":16},"Folic acid 0.5mg",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Materna",[20],"Dietary Supplement: Materna",[22,27],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DIETARY_SUPPLEMENT","Folic acid","women will be randomised into one of the three groups. Group A - Folic acid 5mg\u002Fday Group B - Folic acid 0.5mg\u002Fday Group C - Materna one tablet\u002Fday (a pregnancy supplement containing 0.6mg folic acid)",[15,9],{"type":23,"name":18,"description":18,"armGroupLabels":28,"otherNames":11},[18],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Pui Wah Hui, MD","CONTACT","852-22553402","apwhui@hku.hk",{"type":36,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[38],{"name":39,"class":6},"Queen Mary Hospital, Hong Kong","100386310","effect-of-folic-acid-supplementation-in-pregnant-women-having-thalassaemia-trait-100386310",false,"NCT04310059","Effect of Folic Acid Supplementation in Pregnant Women Having Thalassaemia Trait","A Randomized Controlled Trial to Study the Effect of Folic Acid Supplementation in Pregnant Women Having Thalassaemia Trait","Inclusion Criteria:\n\n* Singleton pregnancy\n* Alpha thalassaemia trait\n* Beta thalassaemia trait\n\nExclusion Criteria:\n\n* Women taking over 0.6mg folic acid daily for 3 months or more prior to and during pregnancy\n* Gestational age \\> 16 weeks at first antenatal visit\n* Women age =\\\u003C 18 years old\n* Booking BMI =\\\u003C 18 or \\>= 35\n* Serum ferritin level \\\u003C 30ug\u002FL or 68 pmol\u002FL\n* Concomitant alpha and beta thalassaemia\n* Hb H disease\n* Beta thalassaemia major\n* Beta thalassaemia intermediate\n* Thalassaemia other than alpha or beta type\n* Women on long term medications\n* Women with risk factors for NTD\n* Women with known epilepsy\n* Women with bariatric surgery or malabsorption diseases\n* Women with known MTHFR polymorphism\n* Vegetarian",true,"FEMALE","18 Years",{"count":51,"type":52},270,"ESTIMATED","INTERVENTIONAL",[55],"NA","Folic acid supplementation has been recommended for prevention of neural tube defects in pregnancy when taken periconceptionally up to 12 weeks of gestation. A daily dose of 0.4mg has been endorsed by World Health Organisation to achieve a Red blood cell (RBC) folate level of 906nmol\u002FL (400ng\u002FmL) for reduction of neural tube defect. Hong Kong has no policy on food fortification. Research data conducted in countries with food fortification may not be applicable. It is therefore essential to study the baseline folate status in pregnant women locally.\n\nFor pregnant women with thalassaemia, they are believed to have a higher risk of folate deficiency because of an increased rate of erythropoiesis and chronic haemolysis. However, information on folate level of thalassaemia trait in pregnancy is scanty. Unmetabolized folic acid has been detected in maternal and fetal blood when daily dosage greater than 0.8-1mg was taken. In term of the dosage and duration of folic acid supplementation after 12 weeks of gestation, the practice varies widely among public hospitals and Maternity \\& Child Health Care centres. It is therefore essential to study the optimal dosage of folic acid supplementation in women with thalassaemia.",[58,59],"Thalassemia","Folic Acid Deficiency Anemia","NOT_YET_RECRUITING","2023-11-27",{"date":63,"type":64},"2023-11-29","ACTUAL",{"date":66,"type":52},"2024-07-01",{"date":68,"type":52},"2026-07-31",{"name":5,"class":6}]