- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03310242
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Sunlight Exposure
Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
|
|
Experimentell: Vitamin D Supplementation
Supplementation of vitamin D3 500 IU/day for 8 weeks
|
- Supplementation of vitamin D3 500 IU/day for 8 weeks
|
Placebo-jämförare: Placebo
Intake of placebo for 8 weeks
|
- Intake of placebo for 8 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Serum 25(OH)D
Tidsram: Baseline, 4 week, and 8 week
|
Changes in serum 25(OH)D levels in ng/mL
|
Baseline, 4 week, and 8 week
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
BMI
Tidsram: 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
Tidsram: Baseline, 4 week, and 8 week
|
Systolic blood pressure changes in mmHg
|
Baseline, 4 week, and 8 week
|
Diastolic blood pressure
Tidsram: Baseline, 4 week, and 8 week
|
Diastolic blood pressure changes in mmHg
|
Baseline, 4 week, and 8 week
|
Lipid panel
Tidsram: Baseline and 8 week
|
Serum total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in mg/dL
|
Baseline and 8 week
|
Fasting glucose
Tidsram: Baseline and 8 week
|
Serum fasting glucose in mg/dL
|
Baseline and 8 week
|
AST
Tidsram: Baseline and 8 week
|
Serum AST levels in mg/dL
|
Baseline and 8 week
|
ALT
Tidsram: Baseline and 8 week
|
Serum ALT levels in mg/dL
|
Baseline and 8 week
|
GGT
Tidsram: Baseline and 8 week
|
Serum AST, ALT, and GGT levels in mg/dL
|
Baseline and 8 week
|
Intact PTH
Tidsram: Baseline and 8 week
|
Serum intact PTH levels in mg/dL
|
Baseline and 8 week
|
Whole body BMD and BMC
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Hee-Kyung Joh, PhD, Seoul National University College of Medicine/Seoul National University Hospital
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-1504-112-668
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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