Altered Calcium and Vitamin D in PMDD or Severe PMS

March 1, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Altered Calcium And Vitamin D Metabolism in PMDD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • St. Luke's-Roosevelt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Interventional Model: PARALLEL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Susan Thys-Jacobs, MD, St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Study Completion

October 1, 2003

Study Registration Dates

First Submitted

April 19, 2000

First Submitted That Met QC Criteria

April 19, 2000

First Posted (ESTIMATE)

April 20, 2000

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2010

Last Update Submitted That Met QC Criteria

March 1, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STHYS-JACOBS (completed)
  • DK57869-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premenstrual Syndrome

Clinical Trials on Measures of calcium and bone turnover

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe