A study to assess the metabolic alterations of cholecalciferol (vitamin D3) after oral administration in elderly volunteers
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0004781
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 10
1) Koreans over 65 years of age at the time of the screening
2) A subject who weighs more than 50kg and weighs less than ±20% of his or her ideal body weight {height cm -100} X 0.9
3) A subject who has been found suitable for the study through physical examination and medical examination by interview with this study plan. i.e. subject who has no congenital or chronic disease and pathological symptoms or findings from a medical examination
4) Diagnosis laboratory test (blood chemistry test, urine test) and 12 electrode ECG results, those who have been deemed suitable for the study
5) A subejct who agree to take shading with clothing, hats and sunscreen (SPF30 or higher) for activities exposed to at least 1 hour of sunlight during the study period at least 10 days prior to the administration of the clinical study drug
6) A subject who agree to prohibit the intake of vitamin D supplements (cod-liver oil, salmon, tuna, catfish, mackerel, sardines, unagi, etc.) or foods (dairy products with enhanced vitamin D content) or vitamin D within at least 10 days from the date of clinical research medication
7) After hearing and fully understanding the detailed description of this clinical study, a subject who voluntarily decided to participate and agreed in writing to comply with the precautions
1) A subject who has or has a history of clinically significant hepatobiliary system, kidney, nervous system, respiratory system, blood and tumor, endocrine system, urinary system, mental disease, musculoskeletal system, immune system, otolaryngology, cardiovascular system
2) A subject who has a past history of gastrointestinal diseases (e.g., dysphagia, esophageal disease, gastritis, duodenitis, ulcer, Crohn's disease, acute or chronic pancreatitis), and gastrointestinal operation (excluding simple appendicitis surgery or hernia surgery) that can affect the absorption of clinical medicine
3) Patients with esophageal disorders that delay esophageal transit, such as esophageal stenosis or achalasia
4) Patients who are unable to sit up or stand upright for more than 30 minutes or who are in long-term immobilization (recovery period after surgery, organ stabilizers, etc)
5) A subject with hypersensitivity or has a clinically significant history of hypersensitivity to drugs and other drugs (aspirin, antibiotics, etc) including vitamin D components
6) Patients with genetic problems such as galctose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption because they contain lactose intolerance
7) Patients with severe renal impairment (creatinine clearance less than 60 mL/min, calculated by the Cockroft-Gault equation from blood creatinint levels)
8) Untreated hypocalcemia patients (serum calcium < 7.0 mg/dL)
9) Hypercalcemia, hypercalciuria, kidney stones or history
Hypercalcemia: calcium levels in the blood exceed 1.2 times the normal upper limit
Hypercalciuria: When the ratio of calcium and creatinine in urine using single urine exceeds 0.2
10) AST or ALT exceeds 1.5 times the upper limit of the reference range or total bilirubin exceeds 1.5 times the upper limit of the reference range
11) Have a history of drug abuse
12) In case of administering metabolic enzyme induction or suppressing drug such as barbital medicine within 1 month
13) In case any specialty drugs, herbla medicines, OTC drugs, or vitamin drugs within 10 days prior to the start of this study are judged by the researchrs to be able to affect the safety of the subjects
14) A subject who participated in other clinical study and bioequivalent study within 6 months prior to the date of administration
15) Complete blood donation within 2 months prior to the date of administration, or component donation within 1 month, or received a blood transfusion within 1 month
16) permanent excessive drinking (greater than 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot drink from 24 hours before admission until the last blood colleciton
17) More than 10 smokers a day on average over the last 3 months
18) A subject who is scheduled or unable to postpone dental treatment (extraction, orthodontics, neurotherapy, etc.) and selective surgery (beauty surgery, LASIK, LASEK, etc.) from the time the agreement is signed until the end of the study
19) A subject who deems the investigator unsuitable for participation in the clinical study for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changed metabolic biomarkers in plasma
- Secondary Outcome Measures
Name Time Method Vital Sign;Physical examination;Adverse event monitoring