Effects of Omega-3 Fatty Acids on Bone and Frailty - Full Text View

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

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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Supplements Diets Osteoporosis

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Calcium gluconate Vitamin D

U.S. FDA Resources

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
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

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:

Arlt W, Callies F, van Vlijmen JC, Koehler I, Reincke M, Bidlingmaier M, Huebler D, Oettel M, Ernst M, Schulte HM, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency. N Engl J Med. 1999 Sep 30;341(14):1013-20.

Callies F, Fassnacht M, van Vlijmen JC, Koehler I, Huebler D, Seibel MJ, Arlt W, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency: effects on body composition, serum leptin, bone turnover, and exercise capacity. J Clin Endocrinol Metab. 2001 May;86(5):1968-72.

Morales AJ, Haubrich RH, Hwang JY, Asakura H, Yen SS. The effect of six months treatment with a 100 mg daily dose of dehydroepiandrosterone (DHEA) on circulating sex steroids, body composition and muscle strength in age-advanced men and women. Clin Endocrinol (Oxf). 1998 Oct;49(4):421-32.

Responsible Party:	University of Connecticut Center on Aging ( Anne Kenny, MD, Associate Professor of Medicine )
Study ID Numbers:	AG0096
Study First Received:	March 11, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00634686 History of Changes
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:

Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Trace Elements
Calcium Carbonate
Bone Diseases
Calcium, Dietary

Vitamin D
Musculoskeletal Diseases
Vitamins
Omega 3 Fatty Acid
Antacids
Micronutrients

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Calcium Carbonate

Bone Diseases
Pharmacologic Actions
Vitamin D
Musculoskeletal Diseases
Vitamins
Antacids
Micronutrients

ClinicalTrials.gov processed this record on September 10, 2009