Study to Evaluate the Effects of Vitamin B3 Derivative on Bone, Skeletal, Muscle and Metabolic Functions in Aging

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-000224
    Sponsor Protocol Number: 18-000224

About this study

The purpose of this study is to evaluate the effects of vitamin B3 derivative on bone, skeletal, muscle and metabolic functions in aging.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Healthy elderly female subjects between 65 and 80 years of age.

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 or a legally authorized representative.
  • 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.
  • 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 stage 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).
  • Pharmacological doses of thyroid hormone (causing decline of TSH below normal).
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Eduardo Chini, M.D., Ph.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20454960

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