Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001598
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
DHEA Treatment for Sjogrens Syndrome
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Dehydroepiandrosterone DHEA Treatment for Sjogrens Syndrome
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of the male hormone dehydroepiandrosterone DHEA in treating Sjogrens syndrome This autoimmune disorder in which the immune system attacks the salivary glands and tear glands affects primarily women Patients eyes and mouth become drier over time and can lead to problems such as serious tooth decay and eye irritations Sex hormones seem to influence the immune response and may help decrease disease severity DHEA has benefited some patients with two other autoimmune diseases rheumatoid arthritis and systemic lupus erythematosus
Women 18 to 75 years of age with Sjogrens syndrome may be eligible for this 7-month study At the initial visit candidates will have a physical examination routine blood and urine tests and eye and dental examinations including a test to measure saliva production for screening purposes and to establish baseline values for participants
Those enrolled in the study will be randomly assigned to take either DHEA or placebo look-alike tablet with no active ingredient once a day for 6 months and will be monitored with follow-up visits at months 1 3 6 and 7 Physical examination blood tests and urinalysis will be repeated at months 1 3 6 and 7 saliva will be collected at months 3 6 and 7 and eyes will be examined at 3 and 6 months Because hormone changes may have both physical and emotional effects patients will be asked questions about their mood symptoms and side effects of treatment
It is not known if Sjogrens syndrome is associated with osteoporosis bone thinning but since this condition occurs in other autoimmune disorders patients bone density will be measured at the first visit and blood drawn at 3 and 6 months will be tested for various substances associated with changes in bone density A 24-hour urine collection at the first visit and later urine tests will also be tested for substances associated with bone thinning
Women 18 to 75 years of age with Sjogrens syndrome may be eligible for this 7-month study At the initial visit candidates will have a physical examination routine blood and urine tests and eye and dental examinations including a test to measure saliva production for screening purposes and to establish baseline values for participants
Those enrolled in the study will be randomly assigned to take either DHEA or placebo look-alike tablet with no active ingredient once a day for 6 months and will be monitored with follow-up visits at months 1 3 6 and 7 Physical examination blood tests and urinalysis will be repeated at months 1 3 6 and 7 saliva will be collected at months 3 6 and 7 and eyes will be examined at 3 and 6 months Because hormone changes may have both physical and emotional effects patients will be asked questions about their mood symptoms and side effects of treatment
It is not known if Sjogrens syndrome is associated with osteoporosis bone thinning but since this condition occurs in other autoimmune disorders patients bone density will be measured at the first visit and blood drawn at 3 and 6 months will be tested for various substances associated with changes in bone density A 24-hour urine collection at the first visit and later urine tests will also be tested for substances associated with bone thinning
Detailed Description:
Primary Sjogrens syndrome SS is an autoimmune disease chiefly affecting the exocrine glands One of the most troublesome manifestations of SS is severe salivary gland dysfunction There is no accepted treatment for the underlying autoimmune reactivity or the salivary gland dysfunction in SS SS as well as many other autoimmune diseases predominantly affects women Although sex hormones do not cause SS or other autoimmune disease they appear to influence immunological responses and ultimately the severity of disease We propose to test the effects of dehydroepiandrosterone DHEA a mildly androgenic adrenal hormone on lacrimal and salivary gland function in SS In a randomized double-masked outpatient protocol patients will receive DHEA for 6 months Efficacy of treatment will be assessed by monitoring salivary and lacrimal function serological markers of autoimmune activity and subjective reports of local and systemic symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-D-0123 | None | None | None |