Healthy subject
Conditions
Interventions
Ingestion of 10 micro grams of Vitamin D3 per day for 112 days
Ingestion of placebo without vitamin D3 for 112 days
Sponsors
FANCL CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.45 to 74 years of age of healthy Japanese subjects 2.BMI between 18.5 to 24.9 kg/m2 3.Defined serum 25-OHD level: less-than-or-equal-to 30 ng/mL (= 75 nmol/L) 4. Subjects willing and able to give written informed consent and to understand, to participate and to comply with the study requirements
Exclusion criteria
Exclusion criteria: 1.Current smoker 2.The subject with a serious illness 3.The subject with an illness that influencing results 4.Subjects who are planning to extensively expose one's body to the sun 5.Fasting glucose >110 mg /dl 6.Use of HRT within the previous 6 months 7.Use of dietary supplements while on study, except multi-vitamins, however must stop before enter the study and refrain until the end of the study 8.Use of Vitamin D supplements 9.Use of high dose Calcium supplements >600 mg 10.Hypertension: higher than 145 / 95 mmHG measured in resting position 11.Treatment for hypertension 12.Subjects with a history of a psychological illness or condition which is likely to interfere with the subject's ability to understand the requirements of the study 13.Systematic practice of high intensity exercise (high intensity sports more than 3 times per week) 14.Any condition that might interfere with absorption of the investigational product 15.Dieases that carry a risk for hypercalcemia: Sarcoidosis, Tuberculosis, Lymphoma, primary hyperparathyroidism 16.Kidney stones 17.Creatinine clearance of less than 30 ml/min 18.Known hypersensitivity or allergy to dairy or milk products 19.Co-medications: Anticoagulants,use of steroids in any form, parathyroid hormone, corticosteroids, thiazide diuretic, Anticonvulsants, antipsychotics, use of any drug that alters fat absorption, e.g. Xenical (Ali). 20.Use of any drug which might interfere with bone metabolism (biphosphonate, hormone replacement therapy, estrogen receptor modulators, calcitonin) within the precious 12 months 21.None-fat diets, or other extreme dietary habits 22.Subjects on a weight reduction program or a medically supervised diet 23.Signs of acute or severe illness: unintentional weight-loss, night sweats, treatment for cancer 24.Alcohol abuse:>=140g /week 25.Persons judged to be unsuitable as trial subjects by the Principal Investigator or Assistant Investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence proportion of upper respiratory tract infection during the test period | — |
Secondary
| Measure | Time frame |
|---|---|
| Longest duration, most severe physical and mental severity of upper respiratory tract infection during the study period Incidence proportion longest duration, most severe physical and mental severity of upper respiratory tract infection of every 4 weeks of study period | — |
Countries
Japan
Contacts
Public ContactYoshiki Shimizu
FANCL CORPORATION Research institute
Outcome results
None listed