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Effects of Omega-3 Fatty Acids on Bone and Frailty

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), March 2008

Sponsors and Collaborators: Donaghue Medical Research Foundation
University of Connecticut
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00634686
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Bone turnover markers [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Mineral Density [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Physical performance measures [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cognitive status, mood and depression [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility
Ages Eligible for Study:   65 Years and older
Genders 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634686

Contacts
Contact: Anne Kenny, MD     860-679-4928     kenny@uchc.edu    

Locations
United States, Connecticut
University of Connecticut Health Center     Recruiting
      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    
  More Information


Publications:

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

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

Study placed in the following topic categories:
Vitamin D
Musculoskeletal Diseases
Ergocalciferols
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008




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