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S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands (SAMe)

Primary Purpose

Osteoarthritis Hand

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
S-Adenosyl-L-Methionine (Sam-E)
Placebo
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis Hand focused on measuring SAMe, S-Adenosyl-L-Methionine

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Current primary care provider at Heater Road Primary Care
  • Office visit at Heater Road clinic in the past 3 years
  • Patient age 50-75 years

  • Discomfort or functional limitations of one or both hands AND either:

    1. Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)* or
    2. existing radiographic evidence of osteoarthritis as judged by a radiologist
  • Patients taking OTC or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study
  • *Objective inclusion criteria (see poster schematic)

Swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (DIP) of each hand, the 2nd and 3rd proximal interphalangeal (PIP) of each hand, and the 1st carpometacarpal joints of both hands.

Exclusion Criteria:

  • Patients taking prescription medications other than NSAIDs for their OA who are unable to stop their medication
  • Patients with diagnoses of arthritis from conditions other than OA
  • Patients whose symptomatic joint is an artificial joint
  • Patients with Bipolar Disorder

  • Patients taking any of the following medications at study entry OR starting any of these medications during the study period:

    1. daily opioids (including tramadol or buprenorphine)
    2. gabapentin or pregabalin
    3. prednisone
    4. Prescription NSAIDs that they are unable to stop, or topical diclofenac
    5. SNRI drugs (Effexor, Cymbalta, Fetzima, Pristiq)
  • The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S-Adenosyl-L-Methionine (SAMe)

Placebo

Arm Description

Participants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Outcomes

Primary Outcome Measures

Determine the effect of SAMe supplements on hand discomfort relative to placebo, as measured by the change in discomfort scores over time on a visual analog scale
Scores range from 0-10, 0 being no discomfort and 10 being maximum discomfort

Secondary Outcome Measures

Determine the effect of SAMe supplementation on quality of life measures regarding hand arthritis, as measured by DASH (Disability of Arm, Shoulder and Hand) survey responses done weekly for 17 weeks
Survey using descriptors of disability and function ranging from no disability to complete disability with 3 other levels of disability in between done weekly for 17 weeks
Determine tolerability of SAMe supplementation compared to placebo, as measured by a survey of 14 common symptoms one may experience from a supplement
14 symptoms queried for occurrence over the week ranging from "Not at All" to "Very Much" with three additional options in between

Full Information

First Posted
May 2, 2022
Last Updated
August 25, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05363020
Brief Title
S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands
Acronym
SAMe
Official Title
S-Adenosyl-L-Methionine (SAMe) vs Placebo for Discomfort and Functional Limitations Associated With Osteoarthritis of the Hands: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to demonstrate the feasibility of evaluating SAMe tolerability, analgesic benefits, and daily functional improvement in patients with osteoarthritis of the hands compared to placebo. The secondary objective of this study is to generate preliminary data on discomfort, function, quality of life in patients with osteoarthritis of the hands when taking SAMe compared to placebo.
Detailed Description
At week 0, all patients giving written informed consent and meeting eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to SAMe (400mg orally, twice daily) or placebo (400mg, twice daily) for 8 weeks. Followed by a one week wash out period followed by another 8 weeks of SAMe (400mg, twice daily) or placebo (400mg, twice daily) for 8 weeks (whichever was not given during the first 8 week period). Participants will complete weekly surveys during the entire study regarding hand discomfort, functional limitations and side effects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Hand
Keywords
SAMe, S-Adenosyl-L-Methionine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-Adenosyl-L-Methionine (SAMe)
Arm Type
Experimental
Arm Description
Participants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.
Intervention Type
Drug
Intervention Name(s)
S-Adenosyl-L-Methionine (Sam-E)
Intervention Description
400 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
400 mg identically appearing placebo
Primary Outcome Measure Information:
Title
Determine the effect of SAMe supplements on hand discomfort relative to placebo, as measured by the change in discomfort scores over time on a visual analog scale
Description
Scores range from 0-10, 0 being no discomfort and 10 being maximum discomfort
Time Frame
Weekly for 17 weeks
Secondary Outcome Measure Information:
Title
Determine the effect of SAMe supplementation on quality of life measures regarding hand arthritis, as measured by DASH (Disability of Arm, Shoulder and Hand) survey responses done weekly for 17 weeks
Description
Survey using descriptors of disability and function ranging from no disability to complete disability with 3 other levels of disability in between done weekly for 17 weeks
Time Frame
Weekly for 17 weeks
Title
Determine tolerability of SAMe supplementation compared to placebo, as measured by a survey of 14 common symptoms one may experience from a supplement
Description
14 symptoms queried for occurrence over the week ranging from "Not at All" to "Very Much" with three additional options in between
Time Frame
Weekly for 17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current primary care provider within the Dartmouth Health system Office visit at Dartmouth Health in the past 3 years Participants must be 40 or older at the time of signing the informed consent Participants have discomfort or functional limitations of one or both hands AND either: Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)* or Existing radiographic evidence of osteoarthritis as judged by a radiologist Patients taking OTC or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study *Objective inclusion criteria (see poster schematic) Swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (DIP) of each hand, the 2nd and 3rd proximal interphalangeal (PIP) of each hand, and the 1st carpometacarpal joints of both hands. Exclusion Criteria: Patients taking prescription medications other than NSAIDs for their OA who are unable to stop their medication Patients with diagnoses of arthritis from conditions other than OA Patients whose symptomatic joint is an artificial joint Patients with Bipolar Disorder Patients taking any of the following medications at study entry OR starting any of these medications during the study period: daily opioids (including tramadol or buprenorphine) gabapentin or pregabalin prednisone Prescription NSAIDs that they are unable to stop or topical diclofenac SNRI drugs (Effexor, Cymbalta, Fetzima, Pristiq) The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott C Jaynes, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands

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