Effects of Omega-3 Fatty Acids on Bone and Frailty

• ClinicalTrials.gov Identifier: NCT00634686
• Recruitment Status: Unknown
• First Posted: March 13, 2008
• Last Update Posted: February 2, 2009
• Sponsor: Donaghue Medical Research Foundation
• Collaborator: University of Connecticut
• Information provided by: National Institute on Aging (NIA)

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• 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

Contacts and Locations

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. doi: 10.1056/NEJM199909303411401.

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. doi: 10.1210/jcem.86.5.7483.

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. doi: 10.1046/j.1365-2265.1998.00507.x.

• Responsible Party: Anne Kenny, MD, Associate Professor of Medicine, University of Connecticut Center on Aging
• ClinicalTrials.gov Identifier: NCT00634686
• Other Study ID Numbers: AG0096
• First Posted: March 13, 2008
• 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; Frailty; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Pathologic Processes; Vitamin D; Calcium; Vitamins; Micronutrients; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Bone Density Conservation Agents