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Omega-3 Fatty Acids
1 for Frailty
Phase 4
Waitlist Available
Led By Anne Kenny, MD
Research Sponsored by Donaghue Medical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenopausal women over 65 years old
Spine or hip bone density T score less than -1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 and 6 months
Awards & highlights
Study Summary
The purpose of this study is to examine the effects of essential fatty acid (EFA) supplementation on bone metabolism and frailty in postmenopausal women. The overall hypothesis is that EFA supplementation, via its immunoregulatory and anti-inflammatory activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with bone metabolism and frailty, and change physical outcome measures associated with frailty in postmenopausal women with low bone mass and frailty.
Eligible Conditions
- Frailty
- Osteoporosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone turnover markers
Secondary outcome measures
Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma
Bone Mineral Density
Cognitive status, mood and depression
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment2 Interventions
Group II: 2Placebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DHA/EPA
2006
Completed Phase 3
~4210
Calcium with vitamin D
2003
N/A
~60
Find a Location
Who is running the clinical trial?
University of ConnecticutOTHER
181 Previous Clinical Trials
158,046 Total Patients Enrolled
3 Trials studying Frailty
288 Patients Enrolled for Frailty
Donaghue Medical Research FoundationLead Sponsor
23 Previous Clinical Trials
578,317 Total Patients Enrolled
Anne Kenny, MDPrincipal InvestigatorUniversity of Connecticut Center on Aging
3 Previous Clinical Trials
261 Total Patients Enrolled
2 Trials studying Frailty
239 Patients Enrolled for Frailty
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