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Sponsors and Collaborators: |
Donaghue Medical Research Foundation University of Connecticut |
Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00634686 |
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.
Condition | Intervention | Phase |
Osteoporosis Frailty |
Dietary Supplement: DHA/EPA Dietary Supplement: Placebo capsule Dietary Supplement: Calcium with vitamin D |
Phase IV |
MedlinePlus related topics: | Dietary Supplements Osteoporosis |
ChemIDplus related topics: | Calcium gluconate Vitamin D Ergocalciferol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Effects of Omega-3 Fatty Acids on Bone and Frailty |
Estimated Enrollment: | 150 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Dietary Supplement: DHA/EPA
1.2 gram capsule daily for 6 months
Dietary Supplement: Calcium with vitamin D
1000 mg of calcium with 1000 IU vitamin D daily for 6 months
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2: Placebo Comparator |
Dietary Supplement: Placebo capsule
daily for 6 months
Dietary Supplement: Calcium with vitamin D
1000 mg of calcium with 1000 IU vitamin D daily for 6 months
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Osteoporosis is a bone thinning disease that results in fractures that occur with minimal trauma. The direct health care costs related to osteoporosis are estimated to be $14 billion per year, comparable to costs in heart failure and asthma. Frailty, or poor physiologic reserve to deal with stressors, is estimated to be 7% in the general population over age 65. The frailty syndrome is characterized by sarcopenia or muscle loss, inflammation, low estrogen, growth hormone and testosterone levels, poor nutrition and disability, and is associated with an increased risk of falls and fracture. Omega-3 fatty acids found in fish oil (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) have been shown to decrease markers of inflammation (cytokines) and decrease death due to heart disease. A number of studies in animals suggest that fish oil (EPA and DHA) supplementation inhibits bone break down, increases calcium absorbed from the diet and enhances calcium in bone. Few studies have assessed the role of n-6 and n-3 fatty acids in the diet in bone disease in humans. As far as we know, no study has evaluated the role of n-3 fatty acids in the frailty syndrome.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne Kenny, MD | 860-679-4928 | kenny@uchc.edu |
United States, Connecticut | |||||
University of Connecticut Health Center | Recruiting | ||||
Farmington, Connecticut, United States, 06030 |
Donaghue Medical Research Foundation |
University of Connecticut |
Principal Investigator: | Anne Kenny, MD | University of Connecticut Center on Aging |
Responsible Party: | University of Connecticut Center on Aging ( Anne Kenny, MD, Associate Professor of Medicine ) |
Study ID Numbers: | AG0096 |
First Received: | March 11, 2008 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00634686 |
Health Authority: | United States: Institutional Review Board |
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