Altered Calcium and Vitamin D in PMDD or Severe PMS

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.

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Key information

Conditions

Premenstrual Syndrome Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Dysphoric Disorder

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Luke's-Roosevelt Hospital

New York, 10019, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measures of calcium and bone turnover

Procedure

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

National Institute of Mental Health (NIMH)

Registry information

Official study title

Altered Calcium And Vitamin D Metabolism in PMDD

Important dates

Study start: 2000
Study completion: 2003
First posted: Apr 20, 2000
Registry last updated: Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed