Cerebral PalsyNCT07757477
Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy
A study testing Sunlight Exposure in people with Cerebral Palsy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Sunlight Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Jun 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, University of Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy at Cipto Mangunkusumo National Referral General Hospital (RSCM)
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:
Read more
- 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.
Read the detailed description
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.
Eligible 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 (<20 ng/mL) will not be included in the study.
Vitamin 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.
During 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.
Researchers 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.
- Conditions
- Cerebral Palsy
- Being tested
- Sunlight Exposure
- Keywords
- Cerebral Palsy, Vitamin D, Children, Sun Exposure
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunlight ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sunlight Exposure | Experimental | Receive sunlight exposure for 10 minutes, three times per week with approximately 30% of body surface area exposed. Receives: Behavioral: Sunlight Exposure |
| Control Group | No intervention | Participants will continue their usual sunlight exposure habits without a structured sunlight exposure program for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum vitamin D level
Change in serum vitamin D concentration from baseline to week 8 after sunlight exposure intervention.
Measured: At the beginning from enrollment and at the end of intervention (after 8 weeks)
Secondary outcomes (2)
Incidence of acute respiratory tract infections (ARTIs)
Occurrence of acute respiratory tract infection episodes during the 8-week study period.
Measured: Throughout the 8-week study period
Acute adverse effects related to sunlight exposure
Occurrence of acute adverse effects during the intervention, including skin redness, discomfort, overheating, or other reported complaints.
Measured: Throughout the 8-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start30 Jun 2026
- Primary completion31 Aug 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasriza Eka Putra, Universitas Indonesia
- Investigators
- Hasriza Eka Putra, dr, Sp.A, Principal investigator, Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757477
- Sponsor's protocol ID
- 26-04-0534
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. The study does not plan to make individual participant data available outside the research team. All research data will be kept confidential, stored securely, and accessed only by authorized members of the research team in accordance with applicable ethical and confidentiality requirements
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy at Cipto Mangunkusumo National Referral General Hospital (RSCM)
- ClinicalTrials.gov ID
- NCT07757477
- Acronym / sponsor ID
- 26-04-0534
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Vitamin D, Children, Sun Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Eligible 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 (<20 ng/mL) will not be included in the study.
Vitamin 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.
During 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.
Researchers 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunlight Exposure | Experimental | Behavioral: Sunlight ExposureReceive sunlight exposure for 10 minutes, three times per week with approximately 30% of body surface area exposed. |
| Control Group | No intervention | –Participants will continue their usual sunlight exposure habits without a structured sunlight exposure program for 8 weeks. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunlight ExposureParticipants 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. | Behavioural | Sunlight Exposure |
Primary outcome
Serum vitamin D level
Time frame: At the beginning from enrollment and at the end of intervention (after 8 weeks)
Change in serum vitamin D concentration from baseline to week 8 after sunlight exposure intervention.
2 secondary outcomes
Incidence of acute respiratory tract infections (ARTIs)
Time frame: Throughout the 8-week study period
Acute adverse effects related to sunlight exposure
Time frame: Throughout the 8-week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The study does not plan to make individual participant data available outside the research team. All research data will be kept confidential, stored securely, and accessed only by authorized members of the research team in accordance with applicable ethical and confidentiality requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasriza Eka Putra, dr, Sp.A principal investigator
Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunlight Exposure in people with Cerebral Palsy, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum vitamin D level (time frame: At the beginning from enrollment and at the end of intervention (after 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.