Premenstrual SyndromeNCT00005119
Altered Calcium and Vitamin D in PMDD or Severe PMS
A study testing Measures of calcium and bone turnover in people with Premenstrual Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Measures of calcium and bone turnover
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2000to Oct 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Amenorrhea
- Anorexia nervosa
- Malabsorption
- Inflammatory bowel disease
- Erosive gastrointestinal disease
- Gastrectomy
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital
New York, New York, 10019
About this study
Official title: Altered Calcium And Vitamin D Metabolism in PMDD
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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Measures of calcium and bone turnover
- Keywords
- Premenstrual Dysphoric Disorder, Severe Premenstrual Syndrome, Calcium metabolism, Vitamin D, Bone Markers, Premenopausal, Menstrual Cycle
- Medical subject headings
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures of calcium and bone turnoverProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2000 (estimated)
- Study startMay 2000
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Susan Thys-Jacobs, MD, Principal investigator, St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005119
- Sponsor's protocol ID
- STHYS-JACOBS (completed)
- Other IDs
- DK57869-01
- Status last verified
- Mar 2010
- First submitted
- 19 Apr 2000
- Last updated
- 2 Mar 2010
- Results posted
- No
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. doi: 10.1007/BF02599520.
PubMed 2656936Thys-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.
PubMed 9731851Thys-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.
PubMed 7608284Lee 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.
PubMed 8199532
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Calcium And Vitamin D Metabolism in PMDD
- ClinicalTrials.gov ID
- NCT00005119
- Acronym / sponsor ID
- STHYS-JACOBS (completed)
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Dysphoric Disorder, Severe Premenstrual Syndrome, Calcium metabolism, Vitamin D, Bone Markers, Premenopausal, Menstrual Cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2000
- Study completion
- Oct 2003
- First posted
- 20 Apr 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- Amenorrhea
- Anorexia nervosa
- Malabsorption
- Inflammatory bowel disease
- Erosive gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measures of calcium and bone turnover | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- BackgroundThys-Jacobs, Silverton M, Alvir JM et al. Reduced Bone Mass in women with Premenstrual Syndrome. J Women's Health 1995; 4:161.
- Background: PubMed 2656936Thys-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.
- Background: PubMed 9731851Thys-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.
- Background: PubMed 7608284Thys-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.
- Background: PubMed 8199532Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Thys-Jacobs, MD principal investigator
St.Luke's-Roosevelt Hospital- Columbia Presbyterian Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measures of calcium and bone turnover in people with Premenstrual Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005119, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.