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Altered Calcium and Vitamin D in PMDD or Severe PMS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005119
First Posted: April 20, 2000
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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.

Condition Intervention
Premenstrual Syndrome Procedure: Measures of calcium and bone turnover

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
Official Title: Altered Calcium And Vitamin D Metabolism in PMDD

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: May 2000
Estimated Study Completion Date: October 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005119


Locations
United States, New York
St. Luke's-Roosevelt Hospital
New York, New York, United States, 10019
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Susan Thys-Jacobs, MD St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005119     History of Changes
Other Study ID Numbers: STHYS-JACOBS (completed)
DK57869-01
First Submitted: April 19, 2000
First Posted: April 20, 2000
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Premenstrual Dysphoric Disorder
Severe Premenstrual Syndrome
Calcium metabolism
Vitamin D
Bone Markers
Premenopausal
Menstrual Cycle

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents