[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659607":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":11,"studyPopulation":11,"armGroups":40,"interventions":61,"overallOfficials":72,"centralContacts":76,"locations":82,"responsibleParty":105,"collaborators":11,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":11,"eligibilityCriteria":112,"healthyVolunteers":109,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":11,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":84,"whyStopped":11,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Aga Khan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Serum 25(OH)D concentrations",null,"16 weeks",[14,17,20,24,26,28,31],{"measure":15,"description":16,"timeFrame":12},"Child weight measurement in kilograms","Weight in kilograms at baseline and endline",{"measure":18,"description":19,"timeFrame":12},"Child dietary diversity","Dietary diversity will also be assessed using a 24-hour food recall on a monthly basis",{"measure":21,"description":22,"timeFrame":23},"Neurocognitive development","Neurocognitive development will be assessed by using Digit span test and Word List Recall.","Baseline and after 6 months of intervention",{"measure":25,"description":11,"timeFrame":12},"Morbidity history",{"measure":27,"description":11,"timeFrame":12},"School attendance",{"measure":29,"description":30,"timeFrame":12},"Child height measurement in centimeters","Height measurement in centimeters at baseline and endline",{"measure":32,"description":33,"timeFrame":12},"Child mid-upper arm circumference measurement in centimeters","Mid-upper arm circumference measurement in centimeters at baseline and endline",{"allocation":35,"interventionModel":36,"interventionModelDescription":11,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":39,"maskingDescription":11,"whoMasked":11},"NONE",[41,47,52,57],{"label":42,"type":43,"description":44,"interventionNames":45},"200 grams of cooked trout fish","EXPERIMENTAL","Group 1: 200 grams of cooked trout fish (100 gram per serving, twice weekly) for 16 weeks, along with education on dietary diversity.",[46],"Other: 200 grams of cooked trout fish",{"label":48,"type":43,"description":49,"interventionNames":50},"250 milliliters of whole cow milk + whole egg","Group 2: 250 milliliters of whole cow milk + whole egg 3 days a week during school hours for 16 weeks, along with education on dietary diversity.",[51],"Other: 250 milliliters of whole cow milk + whole egg",{"label":53,"type":43,"description":54,"interventionNames":55},"Vitamin D supplement 4000 IU weekly","Group 3: Vitamin D supplement 2000 IU twice a week for 16 weeks, along with education on dietary diversity.",[56],"Dietary Supplement: Vitamin D supplement 4000 IU weekly",{"label":58,"type":59,"description":60,"interventionNames":11},"Control Group, no additional meal","NO_INTERVENTION","Group 4: Control Group, no additional meal will be provided during the intervention phase. After the study is completed, these children will receive a vitamin D supplement of 2000 IU twice a week for 16 weeks, along with education on dietary diversity.",[62,66,69],{"type":63,"name":53,"description":64,"armGroupLabels":65,"otherNames":11},"DIETARY_SUPPLEMENT","Vitamin D supplement 4000 IU weekly dose for 16 weeks, along with education on dietary diversity",[53],{"type":6,"name":42,"description":67,"armGroupLabels":68,"otherNames":11},"200 grams of cooked trout fish (100 gram per serving, twice weekly) for 16 weeks, along with education on dietary diversity",[42],{"type":6,"name":48,"description":70,"armGroupLabels":71,"otherNames":11},"250 milliliters of whole cow milk + whole egg 3 days a week during school hours for 16 weeks, along with education on dietary diversity",[48],[73],{"name":74,"affiliation":5,"role":75},"Gul Nawaz Khan, MPH","PRINCIPAL_INVESTIGATOR",[77],{"name":74,"role":78,"phone":79,"phoneExt":80,"email":81},"CONTACT","+92 21 33109538","69538","gul.nawaz@aku.edu",[83],{"facility":5,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"RECRUITING","Karachi","Sindh","74800","Pakistan","PK",{"type":91,"coordinates":92},"Point",[93,94],67.0104,24.8608,{"lat":94,"lon":93},[97,100],{"name":98,"role":78,"phone":99,"phoneExt":11,"email":81},"Gul Nawaz Khan","03008298976",{"name":101,"role":78,"phone":102,"phoneExt":103,"email":104},"Ahmad Khan, MA","+92 21 33109527","69527","ahmad.sherali@aku.edu",{"type":75,"investigatorFullName":98,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Assistant Professor","100659607","impact-of-trout-fish-cow-milk-with-egg-vitamin-d-supplementation-and-dietary-education-on-vitamin-d-status-undernutrition-and-neurocognitive-outcomes-among-school-children-in-pakistan-an-open-label-individually-randomized-controlled-trial-100659607",false,"NCT07864662","Impact of Trout Fish, Cow Milk With Egg, Vitamin D Supplementation, and Dietary Education on Vitamin D Status, Undernutrition, and Neurocognitive Outcomes Among School Children in Pakistan: An Open-label Individually Randomized Controlled Trial","Inclusion Criteria:\n\nChildren will be included in the study if they meet all of the following criteria:\n\n* Aged 6-12 years\n* Enrolled in one of the selected AKESP schools\n* Parent\u002Flegal guardian provides written informed consent\n* Child provides written assent\n* Willing to participate in the full 4-month study period\n* Willing to provide a blood sample for a vitamin D test at baseline and after 4 months\n* Apparently healthy at the time of enrolment\n\nExclusion Criteria:\n\nChildren will be excluded if they meet any of the following criteria:\n\n* Currently enrolled in another research study or regular consumption of nutritional supplements, including vitamin D\n* Known allergy or intolerance to fish, milk, or eggs\n* Diagnosed chronic medical conditions affecting growth or vitamin D metabolism (e.g., renal disease, liver disease, malabsorption disorders)\n* Severe acute illness at the time of enrolment\n* Physical or developmental conditions that prevent participation in study assessments","ALL","6 Years","12 Years",{"count":117,"type":118},304,"ESTIMATED","INTERVENTIONAL",[121],"NA","Vitamin D deficiency and undernutrition are major public health concerns globally, particularly among children in low-resource and high-altitude settings. In Pakistan, the recent national nutrition survey has reported alarmingly high prevalence rates of vitamin D deficiency, especially in Ghizer District of Gilgit-Baltistan, where 85% of children under five years of age are vitamin D deficient, placing them at heightened risk for rickets, impaired growth, weakened immune function, cognitive impairments, and long-term socio-economic consequences. This survey did not provide any information on the vitamin D deficiency status of school-going children in Pakistan. However, a study conducted in Karachi reported that 65% of children aged 6-12 years were deficient in vitamin D. Despite abundant natural resources, such as trout fish and locally available cow's milk and eggs, these nutrient-rich foods are underutilized due to limited awareness among local communities about the health benefits for children.\n\nThis issue is particularly urgent for the Aga Khan University (AKU) and the Aga Khan Education Service Pakistan (AKESP) 's schools in the region, where children's health is integral to academic success and long-term community development. Addressing micronutrient deficiencies aligns closely with AKU's and the Aga Khan Development Network's (AKDN) strategic priorities of improving early childhood development, promoting health equity, strengthening food security, and fostering local capacity through evidence-based interventions.\n\nTherefore, this proposal aims to assess whether targeted local food and supplementation, including trout fish, whole cow milk with egg, and vitamin D supplements, can significantly reduce vitamin D deficiency and improve nutritional and cognitive outcomes among school children in AKESP schools.",[124,125,126],"Vitamin D 25-Hydroxylase Deficiency","Undernutrition","Neurocognitive Development",[128,129,130,131,132,133],"Vitamin D","Trout Fish","Cow Milk","Egg","Vitamin D Supplementation","Dietary Education","2026-10-02",{"date":136,"type":137},"2026-10-08","ACTUAL",{"date":139,"type":137},"2026-08-10",{"date":141,"type":118},"2027-09-30",{"name":5,"class":6},1]