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

NCT07757477 | Completed DMC

• 1 other identifier: 26-04-0534
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Vitamin D; Children; Sun Exposure

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Incidence of acute respiratory tract infections (ARTIs)

  Throughout the 8-week study period

• Acute adverse effects related to sunlight exposure

  Throughout the 8-week study period

Study Arms (2)

Sunlight Exposure

EXPERIMENTAL

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

Behavioral: Sunlight Exposure

Control Group

NO INTERVENTION

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

Interventions

Sunlight Exposure 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.

Sunlight Exposure

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitas Indonesia: lead

Study Sites (1)

Faculty of Medicine, University of Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hasriza Eka Putra, dr, Sp.A

  Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician, Fellow in Pediatric Nutrition and Metabolic Diseases

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: June 30, 2026
• Primary Completion: August 31, 2026
• Study Completion: September 15, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)