[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658788":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":74,"studyPopulation":75,"armGroups":76,"interventions":70,"overallOfficials":83,"centralContacts":88,"locations":97,"responsibleParty":117,"collaborators":121,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":70,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":139,"studyType":140,"phases":70,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":100,"whyStopped":70,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Mahidol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":70},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Mean long-term iron absorption (Fe abs)","Calculated over the duration of the study as follows: Fe abs = k abs x Fe total Where Fe total is the total body iron at the midpoint, calculated from the linear regression of Fe total versus time across each measurement point; and k abs is the fraction of total body iron absorbed per unit of time (derived from the slope of the linear regression equation of ln 57 Fe versus time).\n\n57 Fe isotope will be measured using Inductively Coupled Plasma Mass Spectrometry (ICP-MS).","Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24).",{"measure":14,"description":15,"timeFrame":16},"Mean long-term iron loss (Fe loss)","Calculated in the same manner as iron absorption: Fe loss = k loss x Fe total Where k loss is the fraction of total body iron lost per unit of time.","Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)",{"measure":18,"description":19,"timeFrame":16},"Iron gain (Fe gain)","Calculated as net iron balance: Fe gain = Fe abs - Fe loss",[21,25,29,32,36,40,44,47,51,54,57,60,64,67],{"measure":22,"description":23,"timeFrame":24},"Weight (kg)","Weight will be measured in kg (to the nearest 0.1 kg) using an Inbody digital weighing scale.","Visit 1 (Screening), Visit 3 (Month 9), Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)",{"measure":26,"description":27,"timeFrame":28},"Height (cm)","Height will be measured to the mearest 0.1 cm using a Harpenden stadiometer.","Visit 1 (Screening)",{"measure":30,"description":31,"timeFrame":24},"Body Mass Index (BMI, kg\u002Fm²)","BMI will be calculatedn body weight in kilograms divided by height in meters squared.",{"measure":33,"description":34,"timeFrame":35},"Body composition (fat mass)","Body composition (fat mass) will be measured using the Bioelectrical Impedance Analyzer (BIA; InBody).","Visit 1 (Screening), Visit 4 (after 1 year; WK0), Visits 7 (WK24)",{"measure":37,"description":38,"timeFrame":39},"Nutrient intakes","Nutrient intakes (energy, carbohydrate, protein, fat, iron, zinc, calcium, vitamin C, vitamin A, and fiber) will be calculated from 3-day 24-hr dietary recalls using INMUCAL software.","Visit 2 (Month 0), Visit 3 (Month 9), Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)",{"measure":41,"description":42,"timeFrame":43},"Dietary pattern","Dietary patern from FFQ will be analyzed using the Principal Component Analysis (PCA)","Visit 2 (Month 0), Visit 4 (after 1 year; WK0), Visits 7 (WK24)",{"measure":45,"description":46,"timeFrame":24},"Hemoglobin (Hb, g\u002FL)","Hb concentration will be assessed using flow cytometry",{"measure":48,"description":49,"timeFrame":50},"Serum ferritin (SF, µg\u002FL)","SF will be measured using Enzyme-linked immunosorbent assay (ELISA)","Visit 1 (Screening), Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)",{"measure":52,"description":53,"timeFrame":16},"serum transferrin receptor (sTfR µg\u002FL)","sTfR will be assessed using ELISA",{"measure":55,"description":56,"timeFrame":50},"c-reactive protein (CRP, mg\u002FL)","CRP will measured using ELISA",{"measure":58,"description":59,"timeFrame":50},"alpha-1 acid glycoprotein (AGP, g\u002FL)","AGP will be measured using ELISA",{"measure":61,"description":62,"timeFrame":63},"Glycated hemoglobin (HbA1c, %)","HbA1c wil be measured by Turbidimetric inhibition immunoassay","Visit 3 (Month 9)",{"measure":65,"description":66,"timeFrame":63},"Lipid profile","Lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) will be measured using Enzymatic colorimetric and homogeneous methods.",{"measure":68,"description":69,"timeFrame":63},"Blood pressure (BP, mmHg)","BP will be measured using Omron digital sphygmomanometer",null,{"allocation":70,"interventionModel":70,"interventionModelDescription":70,"primaryPurpose":70,"observationalModel":72,"timePerspective":73,"maskingInfo":70},"COHORT","PROSPECTIVE","1. Research Objective To study iron absorption, loss, and long-term iron gain in overweight or obese middle-aged Thai women compared with normal-weight middle-aged Thai women.\n2. Research Methodology 2.1 Study design: This study is a longitudinal study comparing long-term iron absorption and loss between overweight or obese middle-aged Thai women and normal-weight middle-aged Thai women.\n\n2.2 Study population: The study population consists of 64 women aged 40-50 years, divided into two groups: 32 overweight or obese women, and 32 normal-weight women.\n\n2.3 Research Procedures 2.3.1 Before data collection: The research protocol is submitted for approval to the Central Institutional Review Board, Mahidol University. All data collectors will be trained prior to fieldwork. Upon receiving ethical approval, recruitment posters will be used to invite participants.\n\nScreening process:\n\n1. Interested individuals meeting preliminary eligibility criteria will be informed about study details, sign informed consent, and schedule the first visit for screening and blood collection.\n2. Visit 1 (Screening):\n\n   * Collect demographic and health history, measure weight, height, and body composition.\n   * Collect 5 mL blood sample for Hb, SF, CRP, AGP, and hemoglobin typing.\n   * Perform urine pregnancy test.\n   * Administer one 400 mg albendazole tablet to prevent parasitic infection.\n\nIron isotope administration and follow-up:\n\n2.3.2 Eligible participants will return within 1-2 weeks for the second visit.\n\nVisit 2 (Month 0; M0):\n\nParticipants will consume a 15 mg ⁵⁷Fe isotope solution followed by 100 mg vitamin C drink, then fast for 3 hours.\n\nA snack (plain yogurt and water) will be provided 1.5 hours after ingestion. A 24-hour dietary recall and semi-quantitative food frequency questionnaire (FFQ) will be conducted, with two additional 24-hour recalls by phone (2 weekdays and 1 weekend day).\n\nParticipants will then enter a 1-year equilibration period, recording illness and menstrual data monthly. The research team will monitor via LINE or email.\n\nVisit 3 (Month 9; M9):\n\nCollect fasting blood (5 mL) for Hb, glucose, HbA1c, and lipid profile; measure weight, BP, and conduct 24-hour recall (plus two by phone).\n\nVisit 4 (After 1 year; WK0):\n\nCollect fasting blood (10 mL) for Hb, SF, TfR, CRP, AGP, erythrocyte isotopic enrichment.\n\nMeasure weight, body composition, pregnancy test, and dietary recalls (3 days) and FFQ.\n\nVisits 5-7 (WK8, WK16, WK24):\n\nFor eligible participants, repeat blood tests (7 mL) for Hb, SF, TfR, CRP, AGP, isotopic enrichment, anthropometry, pregnancy test, 3-day dietary recalls, and FFQ.\n\n2.4 Research Instruments\n\n1. General information and medical history questionnaire, 24-hour dietary recall, and FFQ.\n2. Illness and menstrual record forms.\n3. Anthropometry and clinical measures:\n\n   * Weight: InBody digital scale\n   * Height: Harpenden stadiometer\n   * Body composition: Bioelectrical Impedance Analyzer (BIA; InBody)\n   * Blood pressure: Omron digital sphygmomanometer\n4. Laboratory analyses:\n\n   * Hb: Complete Blood Count (CBC) using flow cytometry\n   * SF, TfR, CRP, AGP: ELISA (SFa calculated from SF, CRP, AGP)\n   * Hemoglobin typing: Capillary electrophoresis\n   * Fasting glucose: Enzymatic method\n   * HbA1c: Turbidimetric inhibition immunoassay\n   * Lipids: Enzymatic colorimetric and homogeneous methods\n   * Iron isotopes: Inductively Coupled Plasma Mass Spectrometry (ICP-MS) 2.5 Data Analysis Nutrient intake (energy, carbohydrate, protein, fat, iron, zinc, calcium, vitamin C, vitamin A, and fiber) will be calculated using INMUCAL software.\n\nDietary patterns will be analyzed using Principal Component Analysis (PCA).\n\nThe average iron absorption (Fe\\_abs) over the study period will be calculated as:\n\nFeabs=kabs×FetotalFe\\_{abs} = k\\_{abs} \\\\times Fe\\_{total}Feabs=kabs×Fetotal where Fe\\_total is the total body iron at the midpoint estimated from the regression of Fe\\_total over time, and k\\_abs is the fractional iron absorption rate derived from the slope of the regression line of ln(⁵⁷Fe) vs. time.\n\nAverage iron loss (Fe\\_loss) is calculated similarly:\n\nFeloss=kloss×FetotalFe\\_{loss} = k\\_{loss} \\\\times Fe\\_{total}Feloss=kloss×Fetotal\n\nIron gain (Fe\\_gain) is calculated as:\n\nFegain=Feabs-FelossFe\\_{gain} = Fe\\_{abs} - Fe\\_{loss}Fegain=Feabs-Feloss Differences between groups in general characteristics, biochemical parameters, and iron absorption\u002Floss slopes will be tested using Independent t-test or Mann-Whitney U-test, as appropriate.\n\nA Linear Mixed-Effects Model will be used to analyze group differences in longitudinal changes of iron absorption, loss, and gain.\n\nStatistical significance will be set at p \\\u003C 0.05.","The study population will consist of 64 women aged 40-50 years, divided into two groups: 32 participants who are overweight or obese, and 32 participants with normal weight.",[77,80],{"label":78,"type":70,"description":79,"interventionNames":70},"Normal weight","BMI 18.5-22.9 kg\u002Fm2",{"label":81,"type":70,"description":82,"interventionNames":70},"Overweight or obesity","BMI 25-35 kg\u002Fm2",[84],{"name":85,"affiliation":86,"role":87},"Veronica LOPEZ TEROS, Ph.D.","Internation Atomic Energy Agency","STUDY_DIRECTOR",[89,94],{"name":90,"role":91,"phone":92,"phoneExt":70,"email":93},"Tippawan Pongcharoen, Ph.D.","CONTACT","+66813749901","tippawan.pon@mahidol.ac.th",{"name":95,"role":91,"phone":96,"phoneExt":70,"email":70},"Aree Prachansuwan, Ph.D.","+66890060602",[98],{"facility":99,"status":100,"city":101,"state":70,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Institute of Nutrition","RECRUITING","Nakhon Pathom","73170","Thailand","TH",{"type":106,"coordinates":107},"Point",[108,109],100.04427,13.8196,{"lat":109,"lon":108},[112,114],{"name":90,"role":91,"phone":113,"phoneExt":70,"email":93},"0813749901",{"name":95,"role":91,"phone":115,"phoneExt":70,"email":116},"+890060602","aree.prc@mahidol.ac.th",{"type":118,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":70,"oldOrganization":70},"PRINCIPAL_INVESTIGATOR","Tippawan Pongcharoen","Assistant Professor Dr.",[122],{"name":123,"class":124},"International Atomic Energy Agency","OTHER_GOV","100658788","long-term-iron-absorption-and-loss-in-women-100658788",false,"NCT07855939","Long-term Iron Absorption and Loss in Women","Long-term Iron Absorption and Loss in Overweight\u002FObese Thai Middle-aged Women","Inclusion Criteria:\n\n* Normal weight group\n\n  1. Aged 40-50 years\n  2. Normal weight (BMI 18.5-22.9 kg\u002Fm²)\n  3. Hb ≥12.0 g\u002FdL and inflammation-adjusted SFa \\\u003C50.0 µg\u002FL\n  4. CRP \\\u003C5.0 mg\u002FL\n  5. Normal hemoglobin typing\n  6. Plans to reside in the study area for \\>2 years\n* Overweight\u002Fobese group\n\n  1. Aged 40-50 years\n  2. Overweight or obese \\[Body Mass Index (BMI) ≥25.0 kg\u002Fm²\\] - the BMI cut-off follows the agreement of countries under the Coordinated Research Project (CRP) E43038 \"Using the iron isotope dilution technique to assess the influence of inflammation on long-term iron absorption and loss,\" supported by the IAEA\n  3. Hemoglobin (Hb) ≥12.0 g\u002FdL and inflammation-adjusted serum ferritin (SFa) \\\u003C50.0 µg\u002FL\n  4. C-reactive protein (CRP) between 5.0-25.0 mg\u002FL\n  5. Normal hemoglobin typing\n  6. Plans to reside in the study area for \\>2 years\n\nExclusion Criteria:\n\n* Normal weight group\n\n  1. Having serious medical conditions such as cancer, chronic kidney disease, chronic liver disease, or chronic heart failure\n  2. Having metabolic NCDs (e.g., diabetes, hyperlipidemia, hypertension) requiring hospitalization\n  3. Pregnant, breastfeeding, or planning pregnancy during the study\n  4. Chronic infectious disease (e.g., tuberculosis, AIDS)\n  5. Regular use of anti-inflammatory or other medications (except contraceptives and acne medication)\n  6. Taking vitamin or mineral supplements during or within two weeks prior to the study\n  7. Participating in a weight-loss program\n  8. Known intolerance to iron supplements (e.g., vomiting, diarrhea, abdominal pain, bloating, nausea, or allergic reactions such as rash, breathing difficulty, chest tightness, facial or lip swelling)\n  9. Blood transfusion, blood donation, or significant blood loss during the study or within 6 months before enrollment\n  10. Heavy menstrual bleeding (\\>80 mL\u002Fday, calculated from menstrual record)\n* Overweight\u002Fobese group\n\n  1. Obesity class II (BMI ≥35.0 kg\u002Fm²) with high health risk\n  2. Having serious medical conditions such as cancer, chronic kidney disease, chronic liver disease, or chronic heart failure\n  3. Having metabolic noncommunicable diseases (e.g., diabetes, hyperlipidemia, hypertension) requiring hospitalization\n  4. Pregnant, breastfeeding, or planning pregnancy during the study\n  5. Chronic infectious disease (e.g., tuberculosis, AIDS)\n  6. Regular use of anti-inflammatory or other medications (except contraceptives and acne medication)\n  7. Taking vitamin or mineral supplements during or within two weeks prior to the study\n  8. Participating in a weight-loss program\n  9. Known intolerance to iron supplements (e.g., vomiting, diarrhea, abdominal pain, bloating, nausea, or allergic reactions such as rash, breathing difficulty, chest tightness, facial or lip swelling)\n  10. Blood transfusion, blood donation, or significant blood loss during the study or within 6 months before enrollment\n  11. Heavy menstrual bleeding (\\>80 mL\u002Fday, calculated from menstrual record)",true,"FEMALE","40 Years","50 Years",{"count":137,"type":138},64,"ESTIMATED","18 Months","OBSERVATIONAL","Obese people typically have chronic low-grade inflammation. Based on short-term studies, this inflammation could affect the absorption, utilization, storage, and mobilization of iron, and individuals with inflammation might develop iron deficiency (ID) and anemia when inadequacy of iron intake is presented. The double burden of malnutrition is nowadays emerging as a major public health concern in many countries, including Thailand. Understanding the association of chronic inflammation among people with overweight or obesity (OW\u002FOB) with long-term iron absorption and loss is important for developing appropriate policies and programs to promote iron balance and, consequently, optimal iron status and health outcomes. Since previous reports among Thai women showed a high prevalence of OW\u002FOB and anemia, this study will be conducted to determine the long-term iron absorption and loss among OW\u002FOB free-living women using the iron isotope dilution method.",[143,144],"Obesity & Overweight","Normal Weight Adults",[146,147,148],"low-grade chronic inflammation","long-term iron absorption and loss","Iron isotope","2026-09-28",{"date":151,"type":152},"2026-10-02","ACTUAL",{"date":154,"type":152},"2025-05-08",{"date":156,"type":138},"2028-08-31",{"name":5,"class":6},1]