[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651226":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":28,"studyPopulation":21,"armGroups":29,"interventions":40,"overallOfficials":45,"centralContacts":50,"locations":55,"responsibleParty":72,"collaborators":21,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":21,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":21,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":58,"whyStopped":21,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Indonesia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Serum vitamin D level","Change in serum vitamin D concentration from baseline to week 8 after sunlight exposure intervention.","At the beginning from enrollment and at the end of intervention (after 8 weeks)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Incidence of acute respiratory tract infections (ARTIs)","Occurrence of acute respiratory tract infection episodes during the 8-week study period.","Throughout the 8-week study period",{"measure":19,"description":20,"timeFrame":17},"Acute adverse effects related to sunlight exposure","Occurrence of acute adverse effects during the intervention, including skin redness, discomfort, overheating, or other reported complaints.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE","This study evaluates the effect of sunlight exposure for 8 weeks in increasing serum vitamin D levels among children with cerebral palsy. Children with cerebral palsy have a high risk of vitamin D deficiency due to limited mobility, inadequate nutritional intake, and the use of antiepileptic medications that may interfere with vitamin D metabolism. Sunlight exposure is a natural and accessible source of vitamin D.\n\nEligible participants are children with clinically confirmed cerebral palsy. Children with cerebral palsy who meet the eligibility criteria will be recruited from the Pediatric Clinic and Pediatric Inpatient Unit of Dr. Cipto Mangunkusumo National General Hospital, Jakarta. Children with chronic liver or kidney disease, contraindications to direct sunlight exposure, inability to follow the intervention schedule, severe malnutrition, or baseline vitamin D deficiency (\\\u003C20 ng\u002FmL) will not be included in the study.\n\nVitamin D status will be assessed by measuring serum vitamin D concentration. The assessment will be performed through blood sampling conducted by trained healthcare personnel according to standard medical procedures.\n\nDuring the study, parents or caregivers will be instructed to monitor the child's condition, including signs of discomfort during sunlight exposure such as overheating, skin redness, persistent crying, or other complaints. If participants are unable to complete the exposure in one session due to discomfort, the exposure may be performed gradually within the same day while maintaining the required total duration.\n\nResearchers will monitor adherence to the intervention through scheduled video calls to ensure that the sunlight exposure procedure is performed according to the study protocol. Dietary intake assessment will be performed using food recall and analyzed by the research team.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Sunlight Exposure","EXPERIMENTAL","Receive sunlight exposure for 10 minutes, three times per week with approximately 30% of body surface area exposed.",[35],"Behavioral: Sunlight Exposure",{"label":37,"type":38,"description":39,"interventionNames":21},"Control Group","NO_INTERVENTION","Participants will continue their usual sunlight exposure habits without a structured sunlight exposure program for 8 weeks.",[41],{"type":42,"name":31,"description":43,"armGroupLabels":44,"otherNames":21},"BEHAVIORAL","Participants will receive sunlight exposure for 10 minutes, three times per week between 11:00 AM-1:00 PM Western Indonesia Time (WIB) for 8 weeks, with approximately 30% of body surface area exposed.",[31],[46],{"name":47,"affiliation":48,"role":49},"Hasriza Eka Putra, dr, Sp.A","Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital","PRINCIPAL_INVESTIGATOR",[51],{"name":47,"role":52,"phone":53,"phoneExt":21,"email":54},"CONTACT","+6285291436083","hasriza.eka@ui.ac.id",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Faculty of Medicine, University of Indonesia","RECRUITING","Jakarta Pusat","DKI Jakarta","10430","Indonesia","ID",{"type":65,"coordinates":66},"Point",[67,68],106.8223,-6.1818,{"lat":68,"lon":67},[71],{"name":47,"role":52,"phone":53,"phoneExt":21,"email":54},{"type":49,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Hasriza Eka Putra","Pediatrician, Fellow in Pediatric Nutrition and Metabolic Diseases","100651226","effect-of-sunlight-exposure-on-vitamin-d-levels-in-children-with-cerebral-palsy-100651226",false,"NCT07757477","Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy","The Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy at Cipto Mangunkusumo National Referral General Hospital (RSCM)","Inclusion Criteria:\n\n* Children aged 1-5 years.\n* Diagnosed with cerebral palsy, with the diagnosis clinically confirmed by a pediatrician.\n* Parents or legal guardians provide written informed consent to participate in the study.\n* Covered by the Indonesian National Health Insurance or other insurance.\n\nExclusion Criteria:\n\n* Children with chronic liver disease or chronic kidney disease.\n* Children with contraindications to direct sunlight exposure, such as allergies, hypersensitivity, or skin disorders.\n* Children with severe malnutrition.\n* Children with vitamin D deficiency (baseline serum vitamin D level \\\u003C 20 ng\u002FmL).","ALL","1 Year","5 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this clinical trial is to learn the effect of sunlight exposure on serum vitamin D levels in children aged 1-5 years with cerebral palsy. This study also aims to assess the effect of sunlight exposure on the incidence of acute respiratory tract infections and to evaluate the safety of the intervention.\n\nThe main questions it aims to answer are:\n\n* Does sunlight exposure increase vitamin D levels in children with cerebral palsy?\n* Does sunlight exposure influence the incidence of acute respiratory tract infections in children with cerebral palsy?\n* Does sunlight exposure cause acute adverse effects in children with cerebral palsy?\n\nParticipants will:\n\n* Be randomly assigned to either the sunlight exposure group or the control group.\n* Undergo baseline assessments, including vitamin D levels measurement, anthropometric measurements, dietary assessment, and Fitzpatrick skin phototype assessment before randomization.\n* Receive sunlight exposure for 10 minutes, three times per week between 11:00 AM and 1:00 PM for 8 weeks (intervention group), while participants in the control group will continue their usual sunlight exposure habits.\n* Have caregivers record daily sunlight exposure (intervention group), acute respiratory tract infection episodes, adverse events, and dietary intake during the study period.\n* Undergo repeat vitamin D levels measurement and evaluation of dietary intake, acute respiratory tract infections incidence, and adverse events at the end of the 8-week intervention.",[93],"Cerebral Palsy",[93,95,96,97],"Vitamin D","Children","Sun Exposure","2026-08-11",{"date":100,"type":101},"2026-08-13","ACTUAL",{"date":103,"type":101},"2026-06-30",{"date":105,"type":87},"2026-08",{"name":5,"class":6},1]