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Resveratrol for Osteopenia

N/A

Recruiting

Led By Sheau Ching Chai, PhD, RD

Research Sponsored by University of Delaware

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1 to 5 years postmenopausal women with low bone mass

Timeline

Screening 3 weeks

Treatment Varies

Follow Up bone marker will be assessed before and after 12 weeks and 24 weeks intervention

Awards & highlights

Study Summary

This trial aims to see if taking resveratrol every day can improve the bone health of women after menopause.

Who is the study for?

This trial is for postmenopausal women who are 1 to 5 years into menopause and have low bone mass but not full-blown osteoporosis. Participants should not be on hormone therapy or certain other medications, and must not have a range of conditions from kidney stones to cardiovascular disease. Smokers and those with extreme body weights or allergies to resveratrol-related substances cannot join.Check my eligibility

What is being tested?

The study is testing if taking resveratrol supplements every day can improve bone health in postmenopausal women with low bone mass. It's a comparison between the effects of resveratrol and placebo (a substance with no active drug).See study design

What are the potential side effects?

Potential side effects may include allergic reactions for those sensitive to ingredients related to resveratrol, such as grapes or red wine. Other common side effects are not specified but could mirror typical dietary supplement concerns like digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman who became menopausal between 1 to 5 years ago and have low bone mass.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ bone marker will be assessed before and after 12 weeks and 24 weeks intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~bone marker will be assessed before and after 12 weeks and 24 weeks intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and bone marker will be assessed before and after 12 weeks and 24 weeks intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bone biomarker

Secondary outcome measures

Bone mineral density

Side effects data

From 2013 Phase 2 trial • 24 Patients • NCT02114892

25%

Headache

Abdominal pain

Sickness

100%

80%

60%

40%

20%

Study treatment Arm

Resveratrol

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ResveratrolExperimental Treatment1 Intervention

Dietary Supplement: Resveratrol (500 mg) + 500 mg calcium and 400 IU vitamin D3

Group II: PlaceboPlacebo Group1 Intervention

Dietary Supplement: Placebo (500 mg) + 500 mg calcium and 400 IU vitamin D3

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resveratrol

2014

Completed Phase 3

~730

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,816 Total Patients Enrolled

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

247,078 Total Patients Enrolled

University of DelawareLead Sponsor

154 Previous Clinical Trials

25,177 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for patients to participate in this ongoing clinical trial?

"Data from clinicaltrials.gov confirms that patient recruitment is ongoing for this clinical trial. The study was first listed on 1/2/2024 and last modified on 2/7/2024."

Answered by AI

What is the upper limit for patient participation in this particular research endeavor?

"Indeed, the details provided on clinicaltrials.gov confirm that this trial is actively enrolling subjects. The trial was initially listed on 1/2/2024 and underwent its latest update on 2/7/2024. Recruitment aims to include 34 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Resveratrol for the Prevention of Bone Loss in Postmenopausal Women

2024. "Resveratrol for the Prevention of Bone Loss in Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06250283.