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Trial record 74 of 235 for:    PRASTERONE

Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111930
Recruitment Status : Completed
First Posted : May 27, 2005
Last Update Posted : December 11, 2009
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
The purpose of the study is to examine whether DHEA replacement therapy is associated with beneficial changes in body composition (i.e., increases in lean mass and bone mass, and decreases in fat mass).

Condition or disease Intervention/treatment Phase
Healthy Drug: DHEA Not Applicable

Detailed Description:

The central hypothesis of this study is that restoring circulating levels of the adrenal hormone dehydroepiandrosterone (DHEA) in older people with low levels to more youthful levels will be associated with beneficial changes in lean mass, fat mass and bone mass.

This will be a randomized, placebo-controlled, double-blinded study. Seventy-two men and 72 women, over 60 years old, who are healthy, will be randomized to receive either a replacement dose of DHEA or placebo for 1 year. The replacement dose of DHEA will bring circulating DHEA sulfate (DHEAS) levels into the range of normal in healthy 20-30 year-old women (approximately 8 micromoles per liter [μM] or 295 micrograms per deciliter [µg/dL]) and men (approximately 10 micromoles per liter [μM] or 368 micrograms per deciliter [µg/dL]).

Fat mass and fat-free body mass will be evaluated by dual energy x-ray absorptiometry (DXA), and intra-abdominal fat volume and thigh muscle area will be measured by computed tomography (CT). Bone mineral density (BMD) of the total body, lumbar spine, and proximal femur will be measured by DXA and biochemical markers of bone resorption and formation. Glucose tolerance and insulin response will be evaluated using an oral glucose tolerance test.

If this study confirms the results of a previous preliminary study, the current study is likely to impact future scientific study regarding the role of DHEA deficiency in the biology of aging and its role as a therapeutic agent for the prevention of sarcopenia.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Biological Effects of DHEA in the Elderly
Study Start Date : August 2000
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Primary Outcome Measures :
  1. bone mineral density
  2. body composition

Secondary Outcome Measures :
  1. blood lipids/lipoproteins
  2. glucose tolerance
  3. arterial compliance
  4. visceral adiposity
  5. quality of life
  6. sex steroids and growth factors
  7. sexual health
  8. cognitive function

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy women and men
  • Age 60 or older
  • Age-appropriate DHEAS levels, but 70% lower than normal DHEAS levels for a 25-year old

Exclusion Criteria:

  • Contraindications to DHEA treatment (personal history of breast cancer or other estrogen-dependent neoplasms, acute liver disease, undiagnosed vaginal bleeding in women, history or evidence of prostate cancer or benign prostatic hyperplasia (BPH) in men)
  • Angina
  • Resting blood pressure over 180/95
  • Chronic infections
  • Hypothyroidism
  • Depression
  • Hormone therapy within the previous 6 months
  • Insulin-dependent or poorly controlled diabetes
  • Serum DHEAS level greater than 140 micrograms per deciliter (µg/dL)

Prohibited Medications:

  • Hormone therapy other than stable regimen of thyroid replacement
  • Oral glucocorticoids
  • Insulin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00111930

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United States, Colorado
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States, 80262
Sponsors and Collaborators
National Institute on Aging (NIA)
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Principal Investigator: Wendy M. Kohrt, PhD University of Colorado, Denver

Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00111930     History of Changes
Other Study ID Numbers: AG0019
First Posted: May 27, 2005    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: February 2009
Keywords provided by National Institute on Aging (NIA):
bone mineral density
body composition
lean mass
fat mass
bone mass
decreased DHEAS levels
Additional relevant MeSH terms:
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Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs