NCT00111930

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2005

Completed
Last Updated

December 11, 2009

Status Verified

February 1, 2009

Enrollment Period

4.6 years

First QC Date

May 26, 2005

Last Update Submit

December 9, 2009

Conditions

Healthy

Keywords

dehydroepiandrosteroneDHEASbone mineral densitybody compositionlean massfat massbone massdecreased DHEAS levels

Outcome Measures

Primary Outcomes (2)

  • bone mineral density

  • body composition

Secondary Outcomes (8)

  • blood lipids/lipoproteins

  • glucose tolerance

  • arterial compliance

  • visceral adiposity

  • quality of life

  • +3 more secondary outcomes

Interventions

DHEADRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado at Denver and Health Sciences Center

Denver, Colorado, 80262, United States

Location

Related Publications (6)

  • 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.

    PMID: 15536111BACKGROUND

  • 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.

    PMID: 14561100BACKGROUND

  • 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.

    PMID: 11932279BACKGROUND

  • 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.

    PMID: 10332570BACKGROUND

  • 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.

    PMID: 16735495RESULT

  • 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.

    PMID: 18812486RESULT

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Wendy M. Kohrt, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 26, 2005

First Posted

May 27, 2005

Study Start

August 1, 2000

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

December 11, 2009

Record last verified: 2009-02

Locations

US(1)