Altered Calcium and Vitamin D in PMDD or Severe PMS

Altered Calcium And Vitamin D Metabolism in PMDD

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00005119

Enrollment

Unknown

Registered

2000-04-20

Start date

2000-05-31

Completion date

2003-10-31

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Dysphoric Disorder, Severe Premenstrual Syndrome, Calcium metabolism, Vitamin D, Bone Markers, Premenopausal, Menstrual Cycle

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.

Interventions

PROCEDUREMeasures of calcium and bone turnover

Study design

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026