Vitamin D With Omega-3 or Metformin in Osteoarthritis

NCT06328426 | Not Yet Recruiting

• 1 other identifier: Anti-osteoarthritis
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the efficacy of vitamin D with omega-3 or metformin for reducing knee symptoms and effusion synovitis in patients with symptomatic knee osteoarthritis.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Effusion-synovitis volume on musculoskeletal ultrasound.

  Ultrasound can reveal Joint space narrowing, subchondral sclerosis, and osteophytosis and changes after intervention.

  The measurement will be assessed one day before the treatment and one day after the stoppage of the treatment.

Study Arms (3)

Vtamin D and omega-3.

ACTIVE COMPARATOR

First arm will be treated with vitamin D and omega-3.

Dietary Supplement: Vitamin D; Dietary Supplement: Omega-3

vitamin D and metformin

ACTIVE COMPARATOR

: Second arm will be treated with vitamin D and metformin.

Dietary Supplement: Vitamin D; Drug: Metformin

Placebo

PLACEBO COMPARATOR

Third arm will be treated with placebo.

Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

The dose of Vitamin D will be 1000 IU /day taken orally. The duration of the intervention will be 4 months.

Vtamin D and omega-3.; vitamin D and metformin

Omega-3 DIETARY_SUPPLEMENT

The dose of omega-3 will be 1000 mg /day taken orally. The duration of the intervention will be 4 months.

Vtamin D and omega-3.

Metformin DRUG

The dose of metformin will be 1000 IU /day taken orally. The duration of the intervention will be 4 months.

vitamin D and metformin

Placebo DIETARY_SUPPLEMENT

The duration of the intervention will be 4 months.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Are willing to comply with all study related procedures and assessments. 3. Are ambulatory as defined by ability to complete functional performance testing.
• \. Radiographic evidence of Kellgren-Lawrence grade II-IV osteoarthritis in one or both knees.
• \. Scores 4-10 on the Numerical Rating Scale (NRS) for pain. 6. Stable dose of screening/baseline medications for at least 2 months prior to the anticipated date of study drug dosing.

You may not qualify if:

• Females who are nursing, pregnant or planning to become pregnant during the duration of study drug dosing.
• Subjects who do not have the capacity to consent themselves.
• Subjects who are unable to tolerate oral medication.
• Subjects having previously undergone any of the following treatments in the stated time window:
• Surgery on the Study Knee in the past 6 months.
• Partial or complete joint replacement in the study knee. Partial or complete joint replacement in the contralateral knee is acceptable if the surgery was performed at least 6 months prior to enrollment and the operative knee is asymptomatic.
• Patients who have undergone arthroscopic surgery (including microfracture and meniscectomy) on the Study Knee in the last 2 years prior to the Screening visit or are anticipated to have arthroscopic surgery on either knee at any time during the study period.
• Steroid injection, including extended-release corticosteroid (e.g., Zilretta) within the last 5 months.
• Biologic (platelet-rich plasma, bone marrow, adipose tissue/cells) or hyaluronic acid injection into the Study Knee in the past 6 months.
• Subjects with any of the following drug/medication statuses:
• Currently taking Losartan.
• Currently taking Warfarin or related anticoagulant.
• Opioid analgesics taken in the past 8 weeks and are not willing to discontinue these medications through the duration of the study.
• Drugs that induce significant cellular stress and are not willing to discontinue these medications through the duration of the study, including alkylating agents, anthracyclines, platins, other chemotherapy drugs.
• Subjects with any of the following disease statuses:

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Vitamin D; Docosahexaenoic Acids; Metformin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Adel A Gomaa, Ph.D

CONTACT

+201009534841; a.gomma@aun.edu.eg

Safaa A Mahran, MD

CONTACT

+201003385106; Safaa69@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 25, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: July, 2026
• Access Criteria: Data will become available to interested investigators upon submitting a reasonable research request.