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CompletedNCT03310242Updated Oct 31, 2017

Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels

An interventional study of Sunlight Exposure and Vitamin D Supplementation in Vitamin D Deficiency and Cardiometabolic Risk Factors, sponsored by Seoul National University Hospital. Completed. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jun 2015, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 154 studies testing Vitamin D in Vitamin D Deficiency — 15 open to participants now, 16 under way, none of them phase 3. Vitamin D · Vitamin D Deficiency.

Enrollment
28th of 153
150 · median 75
Started
2015
with 8 others
No phase
87 of 154
12 open now
Registered
89th of 154
by date

Among the 154 studies testing Vitamin D in Vitamin D Deficiency, this one is the 28th largest by enrollment of the 153 interventional ones that give a count, is one of 9 that started in 2015, is one of 87 with no phase, and was the 89th registered.

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

Browse Vitamin D Deficiency studies →

Open to participants now

15 of the 154 studies testing Vitamin D in Vitamin D Deficiency are open now, in 8 countries. Recruiting first, the newest first:

10 more — sign in →

By country, each count listing its studies:

All 15 open studies →

About Vitamin D

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 39 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Vitamin D Deficiency
  • Cardiometabolic Risk Factors

Browse trials for

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Serum 25(OH)vitamin D \< 12ng/mL
  • age between 18 and 39 years
  • Korean men and women

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Sunlight Exposure

    Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks

    Behavioral: Sunlight Exposure

  • Experimental
    Vitamin D Supplementation

    Supplementation of vitamin D3 500 IU/day for 8 weeks

    Dietary Supplement: Vitamin D Supplementation

  • Placebo comparator
    Placebo

    Intake of placebo for 8 weeks

    Other: Placebo

Interventions

  • BehavioralSunlight Exposure

    * Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks * Completing a Sun Diary after sunlight exposure

  • Dietary supplementVitamin D Supplementation

    - Supplementation of vitamin D3 500 IU/day for 8 weeks

  • OtherPlacebo

    - Intake of placebo for 8 weeks

06

What researchers measure

Primary outcomes

  1. Serum 25(OH)D

    Changes in serum 25(OH)D levels in ng/mL

    Time frame: Baseline, 4 week, and 8 week

Secondary outcomes

  1. BMI

    Weight and height will be combined to report BMI in kg/m\^2

    Time frame: Baseline, 4 week, and 8 week

  2. Systolic blood pressure

    Systolic blood pressure changes in mmHg

    Time frame: Baseline, 4 week, and 8 week

  3. Diastolic blood pressure

    Diastolic blood pressure changes in mmHg

    Time frame: Baseline, 4 week, and 8 week

  4. Lipid panel

    Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL

    Time frame: Baseline and 8 week

  5. Fasting glucose

    Serum fasting glucose in mg/dL

    Time frame: Baseline and 8 week

  6. AST

    Serum AST levels in mg/dL

    Time frame: Baseline and 8 week

  7. ALT

    Serum ALT levels in mg/dL

    Time frame: Baseline and 8 week

  8. GGT

    Serum AST, ALT, and GGT levels in mg/dL

    Time frame: Baseline and 8 week

  9. Intact PTH

    Serum intact PTH levels in mg/dL

    Time frame: Baseline and 8 week

  10. Whole body BMD and BMC

    Whole body BMD (g/cm\^2) and BMC (kg) measured by DEXA

    Time frame: Baseline and 8 week

  11. Lean body mass, fat mass, and percent fat

    Lean body mass (kg), fat mass (kg), and percent fat (%) measured by DEXA

    Time frame: Baseline and 8 week

  12. 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

    Time frame: Baseline, 4 week, and 8 week

  13. 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.

    Time frame: Baseline, 4 week, and 8 week

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2015 to primary completion in Nov 2015, 5 months.

Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's 5 months is below that.

Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2017
First posted
Oct 16, 2017
StartActual
Jun 1, 2015
Primary completionActual
Nov 25, 2015
CompletionActual
Nov 30, 2015
Last update
Oct 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310242
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Jun 1, 2015
Primary completion
Nov 25, 2015
Completion
Nov 30, 2015
Last update
Oct 31, 2017

Study contacts

Hee-Kyung Joh, PhD
principal investigator · Seoul National University College of Medicine/Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin D

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