Altered Calcium and Vitamin D in PMDD or Severe PMS

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00005119

First received: April 19, 2000

Last updated: March 1, 2010

Last verified: March 2010

History of Changes

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:

MedlinePlus related topics: Calcium Menstruation Premenstrual Syndrome Vitamin D

Drug Information available for: Calcium Gluconate Vitamin D

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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

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.

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.

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.

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

ClinicalTrials.gov Identifier:	NCT00005119 History of Changes
Other Study ID Numbers:	STHYS-JACOBS (completed), DK57869-01
Study First Received:	April 19, 2000
Last Updated:	March 1, 2010
Health Authority:	United States: Federal Government

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
Calcium, Dietary
Vitamin D
Ergocalciferols

Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013

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