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Vitamin B3 Derivative

Vitamin B3 Derivative for Aging Effects on Bone and Muscle

N/A
Recruiting
Led By Eduardo N Chini, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy elderly female subjects between 65 and 80 years of age
Be older than 65 years old
Must not have
Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min
Sodium fluoride (any history)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial is testing if Nicotinamide Riboside, a vitamin B3 derivative, has any effects on bones, muscles, and metabolism in aging.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical reactions to supplements such as digestive discomfort or allergic reactions. Close monitoring will identify any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy woman aged between 65 and 80.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is severely reduced.
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I have used sodium fluoride before.
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I cannot or will not give my consent to participate.
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I have diabetes and use insulin.
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I have taken bisphosphonates in the last 3 years.
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I have had gastric bypass surgery.
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I have been diagnosed with hypopituitarism.
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I have been treated with denosumab.
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I have an underactive or overactive parathyroid.
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I have used oral or inhaled steroids for more than 3 months.
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I have severe COPD.
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I have a condition that prevents my body from absorbing nutrients properly.
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My diabetes is not well-controlled (HbA1c>8).
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I have been diagnosed with congestive heart failure.
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My BMI is either below 18.5 or above 40.
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I have had a bone fracture in the past year due to osteoporosis.
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I have been diagnosed with acromegaly.
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I have taken estrogen in the last 3 years.
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I have a history of rheumatoid arthritis.
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I have been diagnosed with liver disease before.
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I have had moderate to severe kidney disease in the past.
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I have been diagnosed with Cushing's syndrome.
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I have taken calcitonin in the last 3 years.
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I have been diagnosed with cancer.
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I have been treated with methotrexate before.
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I am currently taking blood thinners.
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I have been treated with parathyroid hormone in the last 3 years.
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I take multivitamins with more than 200 mg of vitamin B3 daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone metabolism
Immunoblot on muscle biopsy samples
Maximal oxygen uptake (VO2 max) test
+4 more
Secondary study objectives
Glucose profile
Hemoglobin A1C
Insulin
+2 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,301 Total Patients Enrolled
Eduardo N Chini, MDPrincipal InvestigatorMayo Clinic

Media Library

Nicotinamide Riboside (Vitamin B3 Derivative) Clinical Trial Eligibility Overview. Trial Name: NCT03818802 — N/A
Healthy Volunteers Research Study Groups: Nicotinamide Riboside, Placebo
Healthy Volunteers Clinical Trial 2023: Nicotinamide Riboside Highlights & Side Effects. Trial Name: NCT03818802 — N/A
Nicotinamide Riboside (Vitamin B3 Derivative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03818802 — N/A
~0 spots leftby Dec 2024