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

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Sponsor changed: Indonesia University to Universitas Indonesia Show 7 more changesShow less
    • Trial completed
    • Enrollment target: estimated 60 to confirmed 62
    • Primary completion date changed from estimate of Aug 2026 to Aug 31, 2026
    • Study completion date changed from estimate of Aug 2026 to Sep 15, 2026
    • Eligibility criteria expanded, about 8 words
    • Study description revised
    • Site details revised
  2. Minor Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 7 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07757477
Lead Sponsor Universitas Indonesia
Conditions
(from sponsor)
Cerebral Palsy
Related terms Cerebral Palsy
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov