Altered Calcium and Vitamin D in PMDD or Severe PMS

Premenstrual Syndrome Clinical Trial

Official title:

Altered Calcium And Vitamin D Metabolism in PMDD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005119
• Other study ID #: STHYS-JACOBS (completed)
• Secondary ID: DK57869-01
• Status: Completed
• Phase: N/A
• First received: April 19, 2000
• Last updated: March 1, 2010
• Start date: May 2000
• Est. completion date: October 2003

Study information

• Verified date: March 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Intervention Model: Parallel Assignment, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Premenstrual Syndrome

Intervention

Procedure:
• Measures of calcium and bone turnover

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Lee SJ, Kanis JA. An association between osteoporosis and premenstrual symptoms and postmenopausal symptoms. Bone Miner. 1994 Feb;24(2):127-34. — View Citation

Thys-Jacobs S, Alvir MJ. Calcium-regulating hormones across the menstrual cycle: evidence of a secondary hyperparathyroidism in women with PMS. J Clin Endocrinol Metab. 1995 Jul;80(7):2227-32. — View Citation

Thys-Jacobs S, Ceccarelli S, Bierman A, Weisman H, Cohen MA, Alvir J. Calcium supplementation in premenstrual syndrome: a randomized crossover trial. J Gen Intern Med. 1989 May-Jun;4(3):183-9. — View Citation

Thys-Jacobs S, Starkey P, Bernstein D, Tian J. Calcium carbonate and the premenstrual syndrome: effects on premenstrual and menstrual symptoms. Premenstrual Syndrome Study Group. Am J Obstet Gynecol. 1998 Aug;179(2):444-52. — View Citation

Thys-Jacobs, Silverton M, Alvir JM et al. Reduced Bone Mass in women with Premenstrual Syndrome. J Women's Health 1995; 4:161.