Effects of Omega-3 Fatty Acids on Bone and Frailty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National Institute on Aging (NIA).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Connecticut
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00634686
First received: March 11, 2008
Last updated: January 29, 2009
Last verified: January 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Omega-3 Fatty Acids on Bone and Frailty

Resource links provided by NLM:


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: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received: March 11, 2008
Last Updated: January 29, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014