Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy
ConditionCerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorIndonesia University
About this trial
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.
The main questions it aims to answer are:
* Does sunlight exposure increase vitamin D levels in children with cerebral palsy? * Does sunlight exposure influence the incidence of acute respiratory tract infections in children with cerebral palsy? * Does sunlight exposure cause acute adverse effects in children with cerebral palsy?
Participants will:
* Be randomly assigned to either the sunlight exposure group or the control group. * Undergo baseline assessments, including vitamin D levels measurement, anthropometric measurements, dietary assessment, and Fitzpatrick skin phototype assessment before randomization. * 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. * Have caregivers record daily sunlight exposure (intervention group), acute respiratory tract infection episodes, adverse events, and dietary intake during the study period. * 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 1-5 years.
Diagnosed with cerebral palsy, with the diagnosis clinically confirmed by a pediatrician.
Parents or legal guardians provide written informed consent to participate in the study.
Covered by the Indonesian National Health Insurance or other insurance.
Disqualifiers
Children with chronic liver disease or chronic kidney disease.
Children with contraindications to direct sunlight exposure, such as allergies, hypersensitivity, or skin disorders.
Children with severe malnutrition.
Children with vitamin D deficiency (baseline serum vitamin D level < 20 ng/mL).
Trial design
Design model
Parallel
Treatments tested in this trial
Sunlight Exposure
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sunlight ExposureExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Serum vitamin D level
Change in serum vitamin D concentration from baseline to week 8 after sunlight exposure intervention.
Time frame
At the beginning from enrollment and at the end of intervention (after 8 weeks)Secondary outcomes
1
Incidence of acute respiratory tract infections (ARTIs)
Occurrence of acute respiratory tract infection episodes during the 8-week study period.
Time frame
Throughout the 8-week study period2
Acute adverse effects related to sunlight exposure
Occurrence of acute adverse effects during the intervention, including skin redness, discomfort, overheating, or other reported complaints.
Time frame
Throughout the 8-week study periodSponsors and contacts
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Source ClinicalTrials.gov