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Altered Calcium and Vitamin D in PMDD or Severe PMS

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Measures of calcium and bone turnover
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Premenstrual Syndrome focused on measuring Premenstrual Dysphoric Disorder, Severe Premenstrual Syndrome, Calcium metabolism, Vitamin D, Bone Markers, Premenopausal, Menstrual Cycle

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • St. Luke's-Roosevelt Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 19, 2000
Last Updated
March 1, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00005119
Brief Title
Altered Calcium and Vitamin D in PMDD or Severe PMS
Official Title
Altered Calcium And Vitamin D Metabolism in PMDD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual Dysphoric Disorder, Severe Premenstrual Syndrome, Calcium metabolism, Vitamin D, Bone Markers, Premenopausal, Menstrual Cycle

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Measures of calcium and bone turnover

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Thys-Jacobs, MD
Organizational Affiliation
St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Thys-Jacobs, Silverton M, Alvir JM et al. Reduced Bone Mass in women with Premenstrual Syndrome. J Women's Health 1995; 4:161.
Results Reference
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PubMed Identifier
2656936
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. doi: 10.1007/BF02599520.
Results Reference
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PubMed Identifier
9731851
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. doi: 10.1016/s0002-9378(98)70377-1.
Results Reference
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PubMed Identifier
7608284
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. doi: 10.1210/jcem.80.7.7608284.
Results Reference
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PubMed Identifier
8199532
Citation
Lee SJ, Kanis JA. An association between osteoporosis and premenstrual symptoms and postmenopausal symptoms. Bone Miner. 1994 Feb;24(2):127-34. doi: 10.1016/s0169-6009(08)80150-x.
Results Reference
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Altered Calcium and Vitamin D in PMDD or Severe PMS

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