CClinicalTrials.gg
CompletedNCT07757477Updated Sep 18, 2026

Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy

An interventional study of Sunlight Exposure in Cerebral Palsy, sponsored by Universitas Indonesia. Completed at 1 site in Indonesia. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Universitas Indonesia · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
1 Year to 5 Years
Sex
All
01

Study 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.

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.
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.

02

Conditions studied

  • Cerebral Palsy

Browse trials for

Keywords

  • Cerebral Palsy
  • Vitamin D
  • Children
  • Sun Exposure
03

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Sunlight Exposure

    Receive sunlight exposure for 10 minutes, three times per week with approximately 30% of body surface area exposed.

    Behavioral: Sunlight Exposure

  • No intervention
    Control Group

    Participants will continue their usual sunlight exposure habits without a structured sunlight exposure program for 8 weeks.

Interventions

  • BehavioralSunlight Exposure

    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.

05

What researchers measure

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 period

  2. 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 period

06

Study locations

1 site
  • Faculty of Medicine, University of Indonesia
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
07

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07757477
Lead sponsor
Universitas Indonesia
Responsible party
Hasriza Eka Putra (Pediatrician, Fellow in Pediatric Nutrition and Metabolic Diseases, Universitas Indonesia) — Principal investigator
First posted
Aug 11, 2026
Start date
Jun 30, 2026
Primary completion
Aug 31, 2026
Completion
Sep 15, 2026
Last update
Sep 18, 2026

Study contacts

Hasriza Eka Putra, dr, Sp.A
principal investigator · Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion