Effects of Omega-3 Fatty Acids on Bone and Frailty

NCT00634686 | Unknown Phase 4

• 1 other identifier: AG0096
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Frailty

Keywords

Omega-3 fatty acids; immune response

Outcome Measures

Primary Outcomes (1)

• Bone turnover markers

  baseline, 3 and 6 months

Secondary Outcomes (4)

• Bone Mineral Density

  baseline, 3 and 6 months

• Physical performance measures

  baseline, 3 and 6 months

• Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma

  baseline, 3 and 6 months

• Cognitive status, mood and depression

  baseline, 3 and 6 months

Study Arms (2)

1

EXPERIMENTAL

Dietary Supplement: DHA/EPA; Dietary Supplement: Calcium with vitamin D

2

PLACEBO COMPARATOR

Dietary Supplement: Placebo capsule; Dietary Supplement: Calcium with vitamin D

Interventions

DHA/EPA DIETARY_SUPPLEMENT

1.2 gram capsule daily for 6 months

1

Placebo capsule DIETARY_SUPPLEMENT

daily for 6 months

2

Calcium with vitamin D DIETARY_SUPPLEMENT

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

1; 2

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Donaghue Medical Research Foundation: lead
• University of Connecticut: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related 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. doi: 10.1056/NEJM199909303411401.

  PMID: 10502590 BACKGROUND

• 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.

  PMID: 11344193 BACKGROUND

• 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.

  PMID: 9876338 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Frailty

Interventions

Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anne Kenny, MD

  University of Connecticut Center on Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 13, 2008
• Study Start: January 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 2, 2009

Record last verified: 2009-01

Locations

US (1)