[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476004":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":18,"responsibleParty":29,"collaborators":18,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":18,"eligibilityCriteria":39,"healthyVolunteers":40,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":18,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":57,"whyStopped":18,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":18},{"fullName":5,"class":6},"Diabetes Foundation, India","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vitamin D supplementation","EXPERIMENTAL","Appropriate diet and physical activity counselling\n\nSupplementation with Vitamin D and oral Calcium- Doses of cholecalciferol (commercial name, Calcirol) 60,000 international units (sachets, dissolved in half glass milk) once per week for eight weeks to intervention group and placebo (Lactose granules) to the placebo group according to the random numbers generated by the computer.\n\nAfter every 24 weeks blood 25 (OH) D levels will be assessed. If the subjects are found to be still deficient then supplementation of cholecalciferol 60,000 IU per week for eight weeks will be repeated. If the 25 (OH) D levels are normal, then cholecalciferol supplementation in doses of 200 international units per day will be given as a maintenance dose.",[13],"Other: Vitamin D supplementation",[15],{"type":6,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"Appropriate diet and physical activity counselling to both groups. Supplementation with Vitamin D and oral Calcium-Doses of cholecalciferol (commercial name, Calcirol) 60,000 IU (sachets, dissolved in half glass milk) once per week for eight weeks for the intervention group and placebo (Lactose granules) to the placebo group according to the random numbers generated by the computer. After every 24 weeks blood 25 (OH) D levels will be assessed. If the subjects are found to be still deficient then supplementation of cholecalciferol 60,000 IU per week for eight weeks will be repeated.If the 25 (OH) D levels are normal, then cholecalciferol supplementation in doses of 200 IU per day will be given as a maintenance dose. Equal doses of calcium carbonate (1gm per day, commercial name Calcal) will be given to both the groups.",[9],null,[20,25],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Anoop Misra, MD","CONTACT","01141759672","anoopmisra@gmail.com",{"name":26,"role":22,"phone":27,"phoneExt":18,"email":28},"SURYA PRAKASH, PhD","09810085720","suryabhat@gmail.com",{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr Anoop Misra","President","100476004","vitamin-d-supplementation-on-surrogate-markers-of-atherosclerosis-100476004",false,"NCT05478291","Vitamin D Supplementation on Surrogate Markers of Atherosclerosis","Effect of Vitamin D Supplementation on Surrogate Markers of Atherosclerosis in North Indian Individuals With Pre-diabetes and Low Vitamin D Levels: a Randomised Controlled Trial.","Inclusion Criteria:\n\n* Pre-diabetes: fasting blood glucose ≥100mg\u002Fdl and \\\u003C125.99mg\u002Fdl, 2-h plasma glucose ≥140mg\u002Fdl and \\\u003C200mg\u002Fdl (after ingestion of 75 g anhydrous oral glucose).\n* Baseline level of 25 hydroxy vitamin D \\\u003C30ng\u002Fdl and aged 20-60 years.\n\nExclusion Criteria:\n\n* Received Vitamin D and\u002For calcium supplementation in the previous six months, on any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (eg metformin, thiazolidione, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steriods, calcitonin etc.)\n* Severe end-organ damage, any malignancy, nephrotic syndrome, malabsorption etc,\n* Known case of HIV infection, hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis)",true,"ALL","20 Years","60 Years",{"count":45,"type":46},120,"ESTIMATED","INTERVENTIONAL",[49],"NA","For this study, our sample population is individuals with prediabetes, who are at an increased risk for atherosclerosis. In this proposed randomized placebo-controlled prospective trial, we would be enrolling 120 subjects with prediabetes having vitamin D deficiency. These subjects will be randomized into two groups; lifestyle modification counselling along with intervention with either vitamin D supplementation or placebo. Clinical and dietary profiles including sunlight exposure, anthropometry, glycemic and lipid profiles, fasting insulin, adiponectin, body composition (DEXA), skinfolds (4 sites), surrogate markers of atherosclerosis\u002Finflammation (TNF-alpha, hs-CRP, Matrix Metalloproteinase-9, flow-mediated dilatation of brachial artery, pulse wave velocity, and carotid intima-mediated thickness) will be measured at week 0 and week.",[52],"Atherosclerosis",[54,55,56],"Vitamin D","Prediabetes","Asian Indians","NOT_YET_RECRUITING","2023-06-13",{"date":60,"type":61},"2023-06-15","ACTUAL",{"date":63,"type":46},"2023-09-01",{"date":65,"type":46},"2026-08-30",{"name":5,"class":6}]