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
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Sunlight Exposure
Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
|
|
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실험적: Vitamin D Supplementation
Supplementation of vitamin D3 500 IU/day for 8 weeks
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- Supplementation of vitamin D3 500 IU/day for 8 weeks
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위약 비교기: Placebo
Intake of placebo for 8 weeks
|
- Intake of placebo for 8 weeks
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum 25(OH)D
기간: Baseline, 4 week, and 8 week
|
Changes in serum 25(OH)D levels in ng/mL
|
Baseline, 4 week, and 8 week
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
BMI
기간: Baseline, 4 week, and 8 week
|
Weight and height will be combined to report BMI in kg/m^2
|
Baseline, 4 week, and 8 week
|
|
Systolic blood pressure
기간: Baseline, 4 week, and 8 week
|
Systolic blood pressure changes in mmHg
|
Baseline, 4 week, and 8 week
|
|
Diastolic blood pressure
기간: Baseline, 4 week, and 8 week
|
Diastolic blood pressure changes in mmHg
|
Baseline, 4 week, and 8 week
|
|
Lipid panel
기간: Baseline and 8 week
|
Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL
|
Baseline and 8 week
|
|
Fasting glucose
기간: Baseline and 8 week
|
Serum fasting glucose in mg/dL
|
Baseline and 8 week
|
|
AST
기간: Baseline and 8 week
|
Serum AST levels in mg/dL
|
Baseline and 8 week
|
|
ALT
기간: Baseline and 8 week
|
Serum ALT levels in mg/dL
|
Baseline and 8 week
|
|
GGT
기간: Baseline and 8 week
|
Serum AST, ALT, and GGT levels in mg/dL
|
Baseline and 8 week
|
|
Intact PTH
기간: Baseline and 8 week
|
Serum intact PTH levels in mg/dL
|
Baseline and 8 week
|
|
Whole body BMD and BMC
기간: Baseline and 8 week
|
Whole body BMD (g/cm^2) and BMC (kg) measured by DEXA
|
Baseline and 8 week
|
|
Lean body mass, fat mass, and percent fat
기간: Baseline and 8 week
|
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
기간: Baseline, 4 week, and 8 week
|
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
기간: Baseline, 4 week, and 8 week
|
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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hee-Kyung Joh, PhD, Seoul National University College of Medicine/Seoul National University Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .