Effects of Omega-3 Fatty Acids on Bone and Frailty

Osteoporosis Clinical Trial

Official title:

Effects of Omega-3 Fatty Acids on Bone and Frailty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00634686
• Other study ID #: AG0096
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 11, 2008
• Last updated: January 29, 2009
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Frailty
• Osteoporosis

Intervention

Dietary Supplement:
• DHA/EPA
1.2 gram capsule daily for 6 months
• Placebo capsule
daily for 6 months
• Calcium with vitamin D
1000 mg of calcium with 1000 IU vitamin D daily for 6 months

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Donaghue Medical Research Foundation	University of Connecticut

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone turnover markers		baseline, 3 and 6 months	No
Secondary	Bone Mineral Density		baseline, 3 and 6 months	No
Secondary	Physical performance measures		baseline, 3 and 6 months	No
Secondary	Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma		baseline, 3 and 6 months	No
Secondary	Cognitive status, mood and depression		baseline, 3 and 6 months	No