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HealthyNCT00111930

Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly

A study testing DHEA in people with Healthy, run by National Institute on Aging (NIA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
DHEA
How many people
144 participants
Where
1 siteUnited States
Study dates
Aug 2000to Mar 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado at Denver and Health Sciences Center

    Denver, Colorado, 80262

Other trials in United States

About this study

Official title: Biological Effects of DHEA in the Elderly

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).

Read the 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.

Conditions
Healthy
Being tested
DHEA
Keywords
dehydroepiandrosterone, DHEAS, bone mineral density, body composition, lean mass, fat mass, bone mass, decreased DHEAS levels

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DHEADrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bone mineral density

  2. body composition

Secondary outcomes (8)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2005 (estimated)
  2. Study startAug 2000
  3. Primary completionMar 2005
  4. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
144 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111930
Sponsor's protocol ID
AG0019
Other IDs
AG018857
Status last verified
Feb 2009
First submitted
26 May 2005
Last updated
11 Dec 2009
Results posted
No

Publications

  • Villareal DT, Holloszy JO. Effect of DHEA on abdominal fat and insulin action in elderly women and men: a randomized controlled trial. JAMA. 2004 Nov 10;292(18):2243-8. doi: 10.1001/jama.292.18.2243.

    PubMed 15536111

  • Legrain S, Girard L. Pharmacology and therapeutic effects of dehydroepiandrosterone in older subjects. Drugs Aging. 2003;20(13):949-67. doi: 10.2165/00002512-200320130-00001.

    PubMed 14561100

  • Kahn AJ, Halloran B, Wolkowitz O, Brizendine L. Dehydroepiandrosterone supplementation and bone turnover in middle-aged to elderly men. J Clin Endocrinol Metab. 2002 Apr;87(4):1544-9. doi: 10.1210/jcem.87.4.8396.

    PubMed 11932279

  • Nippoldt TB, Nair KS. Is there a case for DHEA replacement? Baillieres Clin Endocrinol Metab. 1998 Oct;12(3):507-20. doi: 10.1016/s0950-351x(98)80286-3.

    PubMed 10332570

  • Jankowski CM, Gozansky WS, Schwartz RS, Dahl DJ, Kittelson JM, Scott SM, Van Pelt RE, Kohrt WM. Effects of dehydroepiandrosterone replacement therapy on bone mineral density in older adults: a randomized, controlled trial. J Clin Endocrinol Metab. 2006 Aug;91(8):2986-93. doi: 10.1210/jc.2005-2484. Epub 2006 May 30.

    PubMed 16735495

  • Jankowski CM, Gozansky WS, Kittelson JM, Van Pelt RE, Schwartz RS, Kohrt WM. Increases in bone mineral density in response to oral dehydroepiandrosterone replacement in older adults appear to be mediated by serum estrogens. J Clin Endocrinol Metab. 2008 Dec;93(12):4767-73. doi: 10.1210/jc.2007-2614. Epub 2008 Sep 23.

    PubMed 18812486

Questions about this trial

What is this clinical trial studying?

A study testing DHEA in people with Healthy, run by National Institute on Aging (NIA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bone mineral density. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111930, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.

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