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Effects of Omega-3 Fatty Acids on Bone and Frailty

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ClinicalTrials.gov Identifier: NCT00634686
Recruitment Status : Unknown
Verified January 2009 by National Institute on Aging (NIA).
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2008
Last Update Posted : February 2, 2009
Sponsor:
Collaborator:
University of Connecticut
Information provided by:
National Institute on Aging (NIA)

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Frailty Dietary Supplement: DHA/EPA Dietary Supplement: Placebo capsule Dietary Supplement: Calcium with vitamin D Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Omega-3 Fatty Acids on Bone and Frailty
Study Start Date : January 2007
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 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
Placebo Comparator: 2 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



Primary Outcome Measures :
  1. Bone turnover markers [ Time Frame: baseline, 3 and 6 months ]

Secondary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: baseline, 3 and 6 months ]
  2. Physical performance measures [ Time Frame: baseline, 3 and 6 months ]
  3. Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma [ Time Frame: baseline, 3 and 6 months ]
  4. Cognitive status, mood and depression [ Time Frame: baseline, 3 and 6 months ]


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women over 65 years old
  • Spine or hip bone density T score less than -1
  • Hand grip strength 2 standard deviations below weight adjusted norms
  • Able to travel to the clinical sites for follow-up visits

Exclusion Criteria:

  • Any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism)
  • Cancer of any kind (except basal or squamous cell of skin) in past 5 years.
  • Use of calcitonin, calcitriol, heparin, phenytoin, phenobarbital, and estrogen in the past 6 months
  • Use of bisphosphonates, long-term corticosteroids (more than 6 months), methotrexate, or fluoride at any time
  • Current use of any medication or herbs with anticoagulant or antiplatelet activity, tetracycline, and magnesium or zinc supplementation
  • Estimated creatinine clearance less than 50 ml/min
  • History of chronic liver disease or evidence of liver disease on screening
  • History of hip fracture or known vertebral fracture within the past year
  • Untreated hypertension or a history of clotting disorders
  • History of allergy to fish or fish oil

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634686


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
Donaghue Medical Research Foundation
University of Connecticut
Investigators
Principal Investigator: Anne Kenny, MD University of Connecticut Center on Aging

Publications:
Responsible Party: Anne Kenny, MD, Associate Professor of Medicine, University of Connecticut Center on Aging
ClinicalTrials.gov Identifier: NCT00634686     History of Changes
Other Study ID Numbers: AG0096
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009

Keywords provided by National Institute on Aging (NIA):
Omega-3 fatty acids
immune response

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents