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NCT Number: NCT07757477

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

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 (ARTIs) 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:

* 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 to 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, ARTI incidence, and adverse events at the end of the 8-week intervention.

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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, University of Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location status: Recruiting

Location contact

Hasriza Eka Putra, dr, Sp.A

CONTACT

[email protected]

+6285291436083

About this study

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 using the ARCHITECT 25-OH Vitamin D assay. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Sunlight Exposure

Behavioral

Participants will receive sunlight exposure for 10 minutes, three times per week between 11:00 AM-1:00 PM WIB for 8 weeks, with approximately 30% of body surface area exposed.

Primary outcomes

  1. Serum vitamin D level

    Time frame: At the beginning from enrollment and at the end of intervension (after 8 weeks)

    Change in serum vitamin D concentration from baseline to week 8 after sunlight exposure intervention.

Secondary outcomes

  1. Incidence of acute respiratory tract infections (ARTIs)

    Time frame: Throughout the 8 weeks study period

    Occurrence of acute respiratory tract infection episodes during the 8-week study period.

  2. Acute adverse effects related to sunlight exposure

    Time frame: Throughout the 8 weeks study period

    Occurrence of acute adverse effects during the intervention, including skin redness, discomfort, overheating, or other reported complaints.

Study contacts

Contact information is provided by the study sponsor or research team.

Hasriza Eka Putra, dr, Sp.A

CONTACT

[email protected]

+6285291436083

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy at Cipto Mangunkusumo National Referral General Hospital (RSCM)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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