Effects of Omega-3 Fatty Acids on Bone and Frailty

NCT ID: NCT00634686

Last Updated: 2009-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-06-30

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.

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.

Conditions

Osteoporosis; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

DHA/EPA

Intervention Type: DIETARY_SUPPLEMENT

1.2 gram capsule daily for 6 months

Calcium with vitamin D

Intervention Type: DIETARY_SUPPLEMENT

1000 mg of calcium with 1000 IU vitamin D daily for 6 months

2

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: DIETARY_SUPPLEMENT

daily for 6 months

Calcium with vitamin D

Intervention Type: DIETARY_SUPPLEMENT

1000 mg of calcium with 1000 IU vitamin D daily for 6 months

Interventions

DHA/EPA

1.2 gram capsule daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule

daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Calcium with vitamin D

1000 mg of calcium with 1000 IU vitamin D daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Connecticut

OTHER

Sponsor Role: collaborator

Donaghue Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

University of Connecticut Center on Aging

Principal Investigators

Anne Kenny, MD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut Center on Aging

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10502590 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11344193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9876338 (View on PubMed)

Other Identifiers

AG0096

Identifier Type: -

Identifier Source: org_study_id