Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03818802
Eligibility Criteria:
Inclusion Criteria:
* Healthy elderly female subjects between 65 and 80 years of age
Exclusion Criteria:
* General Exclusion Criteria
* Subjects who participate in regular structured exercise more than 2 hours and 30 min per week or 1hour and 15 min of vigorous exercise per week.
* Unwilling to comply with the follow-up schedule
* Inability or refusal to give informed consent by the patient
* Subject who takes multivitamins containing vitamin B3 derivatives in a dose \> 200 mg/day
* Participation in another investigational drug study within 1 year of treatment
* Laboratory Exclusion Criteria
* Serum 25-hydroxyvitamin D \< 15 ng/ml
* Serum phosphorus \> 5 mg/dL
* Serum alkaline phosphatase 50% above normal limit
* Serum aspartate transaminase 50% above normal limit
* Serum calcium \> 10.5 mg/dL
* Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min Creatinine Clearance \< 50%
* Poorly controlled Diabetes Mellitus (HbA1c\>8)
* Clinical History Exclusion Criteria
* Confirmed diagnosis of Diabetes Mellitus in use of insulin
* Subjects presenting systolic BP\>180 mmHg or a diastolic BP\>90 mmHg on initial evaluation
* Previous diagnosis of liver disease
* Previous chronic kidney disease stages III and IV
* Malignancy
* Malabsorption syndrome
* Hypo- or Hyperparathyroidism
* Acromegaly
* Cushing's syndrome
* Hypopituitarism
* Severe chronic obstructive pulmonary disease
* Congestive heart failure
* Musculoskeletal disorder
* History of rheumatoid arthritis
* Previous gastric bypass surgery
* Clinical history of osteoporotic fracture (spine, hip, or distal forearm) within past year
* Extreme of BMI (≤ 18.5 kg/m2 or ≥ 40 kg/m2)
* Medication Exclusion Criteria
* History of methotrexate therapy
* History of denosumab therapy
* History of oral or inhaled corticosteroid use \> 3 months
* Current use of anticoagulants in general
* Anticonvulsant therapy (within previous year)
* Sodium fluoride (any history)
* Treatment within the past 3 years with bisphosphonates
* Treatment within the past 3 years with parathyroid hormone
* Treatment within the past 3 years with calcitonin
* Treatment within the past 3 years with estrogen
* Treatment within the past 3 years with selective estrogen receptor modulator
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
65 Years
Maximum Age:
80 Years
Study:
NCT03818802
Study Brief:
Protocol Section:
NCT03818802