Vitamin B3 Derivative for Aging Effects on Bone and Muscle

Palo Alto (17 mi)

Overseen byEduardo N Chini, MD

Age: 65+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: Mayo Clinic

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?Researchers are trying to determine if the vitamin B3 derivative Nicotinamide Riboside (NR) has any effects in bone, skeletal muscle, and metabolic functions and structure in aging.

Eligibility Criteria

This trial is for healthy elderly women aged between 65 and 80 who have not been part of another drug study in the last year. They must not have severe kidney, liver, or diabetes issues, nor should they be on certain medications like anticoagulants or steroids.

Inclusion Criteria

I am a healthy woman aged between 65 and 80.

Exclusion Criteria

My kidney function is severely reduced.

I have used sodium fluoride before.

I cannot or will not give my consent to participate.

I have diabetes and use insulin.

I have taken bisphosphonates in the last 3 years.

I have had gastric bypass surgery.

I have been diagnosed with hypopituitarism.

I have been treated with denosumab.

I have an underactive or overactive parathyroid.

I have used oral or inhaled steroids for more than 3 months.

I have severe COPD.

I have a condition that prevents my body from absorbing nutrients properly.

My diabetes is not well-controlled (HbA1c>8).

I have been diagnosed with congestive heart failure.

My BMI is either below 18.5 or above 40.

I have had a bone fracture in the past year due to osteoporosis.

I have been diagnosed with acromegaly.

I have taken estrogen in the last 3 years.

I have a history of rheumatoid arthritis.

I have been diagnosed with liver disease before.

I have had moderate to severe kidney disease in the past.

I have been diagnosed with Cushing's syndrome.

I have taken calcitonin in the last 3 years.

I have been diagnosed with cancer.

I have been treated with methotrexate before.

I am currently taking blood thinners.

I have been treated with parathyroid hormone in the last 3 years.

I take multivitamins with more than 200 mg of vitamin B3 daily.

Treatment Details

The study is testing whether Nicotinamide Riboside (NR), a form of vitamin B3, can improve bone health, muscle function, and metabolism in older adults. Participants will either receive NR or a placebo to compare effects.

2Treatment groups

Active Control

Placebo Group

Group I: Nicotinamide RibosideActive Control1 Intervention

NR is a single chemical moiety containing nicotinamide and ribose. The investigational product is a synthetic NR that is nature-identical to naturally-occurring NR, does not induce flushing or pruritus and has no effect on lipid levels.

Group II: PlaceboPlacebo Group1 Intervention

Correspondent placebo, a pill not containing the active component.

Nicotinamide Riboside is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Niagen for: