Vitamin D DeficiencyNCT03310242
Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels
A study testing Sunlight Exposure and Vitamin D Supplementation in people with Vitamin D Deficiency and Cardiometabolic Risk Factors, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Cardiometabolic Risk Factors
- What is being tested?
- Sunlight Exposure and Vitamin D Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 30 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Serum 25(OH)vitamin D < 12ng/mL
- age between 18 and 39 years
- Korean men and women
Who cannot join
- 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
About this study
Official title: Comparison of Sunlight Exposure and Oral Vitamin D Supplementation on Serum 25-hydroxyvitamin D Concentration and Metabolic Markers in Korean Young Adults: a Randomized Clinical Trial
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.
- Conditions
- Vitamin D Deficiency, Cardiometabolic Risk Factors
- Being tested
- Sunlight Exposure, Vitamin D Supplementation, Placebo
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunlight ExposureBehavioural
- Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
- Completing a Sun Diary after sunlight exposure
Vitamin D SupplementationDietary supplement
- Supplementation of vitamin D3 500 IU/day for 8 weeks
PlaceboOther
- Intake of placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sunlight Exposure | Experimental | Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks Receives: Behavioral: Sunlight Exposure |
| Vitamin D Supplementation | Experimental | Supplementation of vitamin D3 500 IU/day for 8 weeks Receives: Dietary Supplement: Vitamin D Supplementation |
| Placebo | Placebo comparator | Intake of placebo for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D
Changes in serum 25(OH)D levels in ng/mL
Measured: Baseline, 4 week, and 8 week
Secondary outcomes (13)
BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline, 4 week, and 8 week
Systolic blood pressure
Systolic blood pressure changes in mmHg
Measured: Baseline, 4 week, and 8 week
Diastolic blood pressure
Diastolic blood pressure changes in mmHg
Measured: Baseline, 4 week, and 8 week
Lipid panel
Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL
Measured: Baseline and 8 week
Fasting glucose
Serum fasting glucose in mg/dL
Measured: Baseline and 8 week
AST
Serum AST levels in mg/dL
Measured: Baseline and 8 week
ALT
Serum ALT levels in mg/dL
Measured: Baseline and 8 week
GGT
Serum AST, ALT, and GGT levels in mg/dL
Measured: Baseline and 8 week
Intact PTH
Serum intact PTH levels in mg/dL
Measured: Baseline and 8 week
Whole body BMD and BMC
Whole body BMD (g/cm^2) and BMC (kg) measured by DEXA
Measured: Baseline and 8 week
Lean body mass, fat mass, and percent fat
Lean body mass (kg), fat mass (kg), and percent fat (%) measured by DEXA
Measured: Baseline and 8 week
Lean body mass, muscle mass, skeletal muscle mass, fat mass, and percent fat
Lean body mass (kg), muscle mass (kg), skeletal muscle mass (kg), fat mass (kg), and percent fat (%) measured by body impedance analysis
Measured: Baseline, 4 week, and 8 week
EQ-5D-5L
Quality of life measured using EQ-5D-5L scale. The EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health status. In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale. The 5-level version of EQ-5D (EQ-5D-5L) was developed to improve such constraints of the three-level scale.
EQ-5D-5L scale can define 3,125 (=5^5) different health states, and the 5-digit number can be converted into a preference weight which is also referred to as a single weighted index score. The index score of a value set derived from the general population sample can be regarded as a "societal valuation of the respondent's health state" in that country.
Measured: Baseline, 4 week, and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Jun 2015
- Primary completion25 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee-Kyung Joh, PhD, Principal investigator, Seoul National University College of Medicine/Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310242
- Sponsor's protocol ID
- H-1504-112-668
- Status last verified
- Jun 2016
- First submitted
- 31 Jul 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30987813
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sunlight Exposure and Oral Vitamin D Supplementation on Serum 25-hydroxyvitamin D Concentration and Metabolic Markers in Korean Young Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03310242
- Acronym / sponsor ID
- H-1504-112-668
- Conditions
- Vitamin D Deficiency, Cardiometabolic Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 25 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sunlight Exposure | Experimental | Behavioral: Sunlight ExposureEveryday sunlight exposure around noon for 20-30 minutes for 8 weeks |
| Vitamin D Supplementation | Experimental | Dietary Supplement: Vitamin D SupplementationSupplementation of vitamin D3 500 IU/day for 8 weeks |
| Placebo | Placebo comparator | Other: PlaceboIntake of placebo for 8 weeks |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Serum 25(OH)vitamin D < 12ng/mL
- age between 18 and 39 years
- Korean men and women
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunlight Exposure* Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks * Completing a Sun Diary after sunlight exposure | Behavioural | Sunlight Exposure |
| Vitamin D Supplementation- Supplementation of vitamin D3 500 IU/day for 8 weeks | Dietary supplement | Vitamin D Supplementation |
| Placebo- Intake of placebo for 8 weeks | Other | Placebo |
Primary outcome
Serum 25(OH)D
Time frame: Baseline, 4 week, and 8 week
Changes in serum 25(OH)D levels in ng/mL
13 secondary outcomes
BMI
Time frame: Baseline, 4 week, and 8 week
Systolic blood pressure
Time frame: Baseline, 4 week, and 8 week
Diastolic blood pressure
Time frame: Baseline, 4 week, and 8 week
Lipid panel
Time frame: Baseline and 8 week
Fasting glucose
Time frame: Baseline and 8 week
AST
Time frame: Baseline and 8 week
ALT
Time frame: Baseline and 8 week
GGT
Time frame: Baseline and 8 week
Intact PTH
Time frame: Baseline and 8 week
Whole body BMD and BMC
Time frame: Baseline and 8 week
Lean body mass, fat mass, and percent fat
Time frame: Baseline and 8 week
Lean body mass, muscle mass, skeletal muscle mass, fat mass, and percent fat
Time frame: Baseline, 4 week, and 8 week
EQ-5D-5L
Time frame: Baseline, 4 week, and 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 30987813Joh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Kyung Joh, PhD principal investigator
Seoul National University College of Medicine/Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sunlight Exposure and Vitamin D Supplementation in people with Vitamin D Deficiency and Cardiometabolic Risk Factors, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH)D (time frame: Baseline, 4 week, and 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.