Altered Calcium and Vitamin D in PMDD or Severe PMS - Tabular View

Tracking Information

First Received Date ^ICMJE

April 19, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00005119 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Altered Calcium and Vitamin D in PMDD or Severe PMS

Official Title ^ICMJE

Altered Calcium And Vitamin D Metabolism in PMDD

Brief Summary

Osteoporosis has become one of the most widely recognized disorders of our times affecting an estimated 25 million women in this country. Recent evidence has suggested that premenstrual syndrome (PMS) is associated with a calcium deficiency state and bone loss. This may place premenopausal women at greater risk for osteoporosis. An entity such as PMS may be an important physiological marker of a calcium disturbance. The purpose of this investigation is to understand more completely the extent to which calcium balance is disturbed in severe PMS or Premenstrual Dysphoric Disorder (PMDD) by utilizing new tools to assess calcium and bone turnover. The long term objective is to elucidate the pathophysiology of PMDD or severe PMS as it relates to calcium hormones and bone markers. The experimental design involves the comparison between women witn severe PMS and asymptomatic controls.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Parallel Assignment

Condition ^ICMJE

Premenstrual Syndrome

Intervention ^ICMJE

Procedure: Measures of calcium and bone turnover

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Medical history of severe PMS for the PMS group
No medical history of PMS for the control group
Prospective 2 month documentation of moderate to severe symptoms for the PMS group
Prospective 2 month documentation of absent symptoms for the control group
General good health
Regular menstrual cycles
No history of metabolic bone disease

Exclusion Criteria:

Amenorrhea
Anorexia nervosa
Malabsorption
Inflammatory bowel disease
Erosive gastrointestinal disease
Gastrectomy
Malignancy
Multiple myeloma
Primary hyperparathyroidism
Use of suppressive doses of thyroxine
Cushing's syndrome
Use of glucocorticoids or anticonvulsants
Use of diuretics
Metabolic bone disease
Pregnancy or perimenopause or menopause
Mental retardation
Menstrual irregularity
Significant gynecologic abnormality
Use of birth control pills

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00005119

Responsible Party

Study ID Numbers ^ICMJE

STHYS-JACOBS, DK57869-01

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Principal Investigator:

Susan Thys-Jacobs, MD

St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

January 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP