Vitamin D deficiency, unspecified MedDRA version: 8.0 Level: LLT Classification code 10047626
Conditions
Interventions
Product Name: Vitamin D3
Pharmaceutical Form: Tablet
INN or Proposed INN: colecalciferol
Other descriptive name: cholecalciferol, (5Z, 7E)-9,10-secocholesta-5,7,10(19)-trien-3ß-ol, activated 7-dehydro
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject is a man or a woman aged = 70 years at the time of consent. • Subject is judged to be in satisfactory health based on medical history, physical examination, and laboratory screening evaluation. • Subject is willing and able to limit direct sunlight exposure during the course of the study and to apply sunscreen (SPF 15 or greater) to exposed skin if anticipating exposure to direct sunlight for a period of time exceeding 15 minutes at any time. Note: sunbathing and tanning salons will be prohibited. • The subject is ambulatory and can walk 10 feet without a walking aid. • The subject has a serum 25(OH)D level = 6 ng/mL but = 20 ng/mL at screening (Visit 1). • If the subject has a serum 25(OH) D level = 6 ng/mL but = 9 ng/mL at screening (Visit 1), he/she does not have: i. 24-hour urine calcium levels 24 on the Folstein's State Examination (MMSE) at screening (Visit 1)." Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General • Subject has any form of neurological impairments that would preclude accurate determination of sway or SPPB tests, such as but not limited to Parkinson’s disease, essential tremors, seizures, and muscular dystrophy. • Subject has a significant end-organ disease, i.e. genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, psychiatric, or pulmonary disease which, in the opinion of the investigator or SPONSOR, may pose an added risk to the subject or impair the subject’s ability to complete the trial or confound the results. • Subject has a physical impairment that prevents him/her from undergoing evaluations required in the protocol. • Subject has had a myocardial infarction within 6 months of the screening visit (Visit 1). • Subject has uncontrolled hypertension (i.e. sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg). Note: This criterion allows for the adjustment of the subject’s medication. However, stability in the antihypertensive therapy must be achieved for a subject to be eligible for the study. • Subject has a history of any form of cancer, with the following exceptions: i. Adequately treated superficial basal or squamous cell carcinoma of the skin or cervical carcinoma in situ. ii. Solid tumor definitively treated without any history of recurrence for at least 5 years prior to screening (Visit 1). iii. Breast cancer = Stage II and tumor size 100 IU/day) for the total duration of the study, including the placebo run-in phase. These include fortified juices, multivitamins, and fish oil supplements or other animal extracts. Note: Use of other vitamins (such as vitamin A, vitamin B series, and vitamin C) and of minerals is permitted in the study. Subjects may also consume milk or fish. • Subject is currently receiving or previously received treatment with any of the following agents: o Treatment with vitamin D in excess of 800 IU/day at screening (Visit 1), or within 6 months of the screening visit (Visit 1). o Treatment with any active metabolites of vitamin D at screening (Visit 1), or within 6 months of the screening visit (Visit 1); (e.g. 1,25(OH)2 D3 [calcitriol] or 1-alpha-hydroxyvitamin D3 [alfacalcidol]). o Treatment with anabolic steroids (including testosterone) or oral glucocorticoids at screening (Visit 1), or within 12 months of to the screening visit (Visit 1). o Treatment with growth hormone at screening (Visit 1), or within 12 months of the screening visit (Visit 1). o Treatment with any drug that may interfere w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare change in mediolateral body sway (measured with eyes open using the AccuSwayPLUS platform) following administration of vitamin D3 8400 IU once-weekly for 16 weeks to that following administration of placebo in men and women over 70 years old.;Secondary Objective: In men and women over 70 years old: (1) To evaluate the safety and tolerability of vitamin D3 8400 IU administered once-weekly for 16 weeks relative to placebo. (2) To compare the change in functional status assessed using the Short Physical Performance Battery (SPPB) following administration of vitamin D3 8400 IU once-weekly for 16 weeks to placebo. (3) To evaluate the mean serum 25-hydroxyvitamin D [25(OH)D], calcium, and phosphate levels following administration of vitamin D3 8400 IU once-weekly for 16 weeks relative to placebo. (4) If the response to treatment with vitamin D3 is not universal across subjects, to determine the baseline serum 25(OH)D concentration in the subgroup of subjects in whom body sway improved in response to 16 weeks treatment with vitamin D3 8400 IU.;Primary end point(s): The primary efficacy endpoint will be body sway. Other endpoints include SPPB, and serum 25(OH)D, calcium, and phosphate levels. | — |
Countries
Germany
Outcome results
None listed