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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Cardiometabolic Risk Factors
• Intervention / Treatment: Behavioral: Sunlight Exposure; Dietary supplement: Vitamin D Supplementation; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunlight Exposure; Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks	Behavioral: Sunlight Exposure; Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks; Completing a Sun Diary after sunlight exposure
Experimental: Vitamin D Supplementation; Supplementation of vitamin D3 500 IU/day for 8 weeks	Dietary supplement: Vitamin D Supplementation; - Supplementation of vitamin D3 500 IU/day for 8 weeks
Placebo Comparator: Placebo; Intake of placebo for 8 weeks	Other: Placebo; - Intake of placebo for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum 25(OH)D	Changes in serum 25(OH)D levels in ng/mL	Baseline, 4 week, and 8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Weight and height will be combined to report BMI in kg/m^2	Baseline, 4 week, and 8 week
Systolic blood pressure	Systolic blood pressure changes in mmHg	Baseline, 4 week, and 8 week
Diastolic blood pressure	Diastolic blood pressure changes in mmHg	Baseline, 4 week, and 8 week
Lipid panel	Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL	Baseline and 8 week
Fasting glucose	Serum fasting glucose in mg/dL	Baseline and 8 week
AST	Serum AST levels in mg/dL	Baseline and 8 week
ALT	Serum ALT levels in mg/dL	Baseline and 8 week
GGT	Serum AST, ALT, and GGT levels in mg/dL	Baseline and 8 week
Intact PTH	Serum intact PTH levels in mg/dL	Baseline and 8 week
Whole body BMD and BMC	Whole body BMD (g/cm^2) and BMC (kg) measured by DEXA	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	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	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.	Baseline, 4 week, and 8 week

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee-Kyung Joh, PhD, Seoul National University College of Medicine/Seoul National University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): November 25, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 29, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: H-1504-112-668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No