Clinical trial NCT00005119: Altered Calcium and Vitamin D in PMDD or Severe PMS
Official title: Altered Calcium And Vitamin D Metabolism in PMDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Premenstrual Dysphoric Disorder
Severe Premenstrual Syndrome
Calcium metabolism
Vitamin D
Bone Markers
Premenopausal
Menstrual Cycle
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2000-04-20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital
state: New York
Study officials:
affiliation: St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center
name: Susan Thys-Jacobs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thys-Jacobs, Silverton M, Alvir JM et al. Reduced Bone Mass in women with Premenstrual Syndrome. J Women's Health 1995; 4:161.
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.
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.
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.
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.