Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000613
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
1999-10-27
Brief Title:
CVD Risk and Health in Postmenopausal Phytoestrogen Users
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
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:
To determine the acceptability and benefits of use of a dietary supplement of the phytoestrogen genistein versus placebo on heart disease risk factors bone density and psychosocial outcomes in postmenopausal women
Detailed Description:
BACKGROUND
Estrogen replacement therapy is beneficial for heart disease risk factors as well as for bone density However a large proportion of postmenopausal women are not compliant with therapeutic regimens Phytoestrogens are naturally occurring compounds found in plants and soy products that have estrogenic effects and may represent an alternative treatment for the prevention of heart disease and osteoporosis in postmenopausal women However few intervention trials have examined the extent to which it is possible to improve heart disease risk factors bone density and quality of life in postmenopausal women through use of a dietary supplement of phytoestrogen
DESIGN NARRATIVE
Randomized double-blind placebo-controlled study A total of 210 women were enrolled in the study to be followed for one to two years The women were randomized to phytoestrogen treatment or to placebo Data are collected at baseline visits at one and three month follow-up telephone calls and at 6 12 and 24 month follow-up clinic visits Measures of high density lipoprotein and other heart disease risk factors hip and spine bone density and depression life satisfaction and quality of well-being are obtained Cross-sectional and longitudinal comparisons of treatment and placebo groups are performed before and after adjustment and stratification for potentially confounding covariates
The study was renewed in March 2002 to assess whether the women treated with phytoestrogens had lowered homocysteine interleukin-6 C-reactive protein E-selectin and decreased obesity and fat mass over two years
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Estrogen replacement therapy is beneficial for heart disease risk factors as well as for bone density However a large proportion of postmenopausal women are not compliant with therapeutic regimens Phytoestrogens are naturally occurring compounds found in plants and soy products that have estrogenic effects and may represent an alternative treatment for the prevention of heart disease and osteoporosis in postmenopausal women However few intervention trials have examined the extent to which it is possible to improve heart disease risk factors bone density and quality of life in postmenopausal women through use of a dietary supplement of phytoestrogen
DESIGN NARRATIVE
Randomized double-blind placebo-controlled study A total of 210 women were enrolled in the study to be followed for one to two years The women were randomized to phytoestrogen treatment or to placebo Data are collected at baseline visits at one and three month follow-up telephone calls and at 6 12 and 24 month follow-up clinic visits Measures of high density lipoprotein and other heart disease risk factors hip and spine bone density and depression life satisfaction and quality of well-being are obtained Cross-sectional and longitudinal comparisons of treatment and placebo groups are performed before and after adjustment and stratification for potentially confounding covariates
The study was renewed in March 2002 to assess whether the women treated with phytoestrogens had lowered homocysteine interleukin-6 C-reactive protein E-selectin and decreased obesity and fat mass over two years
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL057790 | NIH | None | httpsreporternihgovquickSearchR01HL057790 |