Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
This study aimed to compare the effects between sunlight exposure and oral vitamin D supplementation on serum 25-hydroxyvitamin D concentration and metabolic markers in Korean young adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2015
CompletedFirst Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
October 16, 2017
CompletedOctober 31, 2017
June 1, 2016
6 months
July 31, 2017
October 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Serum 25(OH)D
Changes in serum 25(OH)D levels in ng/mL
Baseline, 4 week, and 8 week
Secondary Outcomes (13)
BMI
Baseline, 4 week, and 8 week
Systolic blood pressure
Baseline, 4 week, and 8 week
Diastolic blood pressure
Baseline, 4 week, and 8 week
Lipid panel
Baseline and 8 week
Fasting glucose
Baseline and 8 week
- +8 more secondary outcomes
Study Arms (3)
Sunlight Exposure
EXPERIMENTALEveryday sunlight exposure around noon for 20-30 minutes for 8 weeks
Vitamin D Supplementation
EXPERIMENTALSupplementation of vitamin D3 500 IU/day for 8 weeks
Placebo
PLACEBO COMPARATORIntake of placebo for 8 weeks
Interventions
* Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks * Completing a Sun Diary after sunlight exposure
\- Supplementation of vitamin D3 500 IU/day for 8 weeks
Eligibility Criteria
You may qualify if:
- Serum 25(OH)vitamin D \< 12ng/mL
- age between 18 and 39 years
- Korean men and women
You may not qualify if:
- Vitamin D supplementation within 2 months
- Photosensitivity or UV allergy
- History of hyperparathyroidism/hypercalciuria/kidney stone/skin cancer and other cancer
- Under medication for hypertension, dyslipidemia, and diabetes
- Intake of photosensitive medicine during study period
- Exposure of strong UV (e.g., beach, sun tanning) during study period
- Pregnant/breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Joh HK, Hwang SS, Cho B, Lim CS, Jung SE. Effect of sun exposure versus oral vitamin D supplementation on serum 25-hydroxyvitamin D concentrations in young adults: A randomized clinical trial. Clin Nutr. 2020 Mar;39(3):727-736. doi: 10.1016/j.clnu.2019.03.021. Epub 2019 Mar 21.
PMID: 30987813DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Kyung Joh, PhD
Seoul National University College of Medicine/Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2017
First Posted
October 16, 2017
Study Start
June 1, 2015
Primary Completion
November 25, 2015
Study Completion
November 30, 2015
Last Updated
October 31, 2017
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share