Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000364673
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
12/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of nutritional supplementation on premenstrual syndrome
Scientific title
The effects of nutritional supplementation on premenstrual syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premenstrual Syndrome 459 0
Condition category
Condition code
Reproductive Health and Childbirth 536 536 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
STUDY TREATMENT ARMS
Group1: Calcium and magnesium and a placebo tablet
Group 2: Calcium and magnesium and a multivitamin and mineral tablet
Intervention code [1] 275 0
Treatment: Other
Comparator / control treatment
Group 3: Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 621 0
The primary outcome measure for PMS is the Premenstrual Symptom Complex Score, (derived from the Menstrual Health Questionnaire). This is assessed from the means of 23 daily individual symptom ratings and is calculated as shown below.

Luteal Phase Score â¿¿ Follicular Phase Score x 100
Luteal Phase Score

Efficacy is defined as a 20% difference between the premenstrual symptom complex score of those on either of two different dietary supplements compared to those on the placebo.
Timepoint [1] 621 0
Subjects will record these details in a daily diary.
Secondary outcome [1] 1291 0
1. Serum magnesium ion
Timepoint [1] 1291 0
Laboratory investigation of the following parameters would be undertaken at two points during the study at commencement of treatment and at completion. Blood will be taken for safety monitoring and the following study parameters in the treatment cohort.
Secondary outcome [2] 1292 0
2. Serum calcium ion concentration.
Timepoint [2] 1292 0
Laboratory investigation of the following parameters would be undertaken at two points during the study at commencement of treatment and at completion. Blood will be taken for safety monitoring and the following study parameters in the treatment cohort.
Secondary outcome [3] 1293 0
Quality of life will be assessed with the SF-12 questionnaire.
Timepoint [3] 1293 0

Eligibility
Key inclusion criteria
1. Subject has a regular menstrual cycle of 25 to 35 days. 2. Subject's general health is normal. 3. Subject has had symptoms of PMS in the last year. 4. Subject is willing to cease taking other supplements for the period of the trail. 5. Subject is willing to comply with the study protocol.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject is currently pregnant or lactating. 2. Subject who is of childbearing age who is not surgically sterile, who is 1) not using effective contraception, and 2) does not agree to have a pregnancy test monthly during the study. 3. Subject is currently taking regular medication or dietary supplement(s) and is unwilling to cease. 4. Subject self reports that they are experiencing undue stress/relationship problems. 5. Subject has any significant disease or disorder. 6. Subject is currently undergoing treatment for PMS. 7. Subject commenced oral contraceptives in the three months prior to commencement. 8. Subject changed oral contraceptives in the three months prior to commencement. 9. Subject has had adverse effects from supplements and/or drugs. 10. Subjects who are taking steroids. 11. Subjects with parathyroid disorders. 12. Subjects with thyroid disorders. 13. Subjects with affective disorders. 14. Subjects who experience photosensitive skin reactions or hypersensitivity to ginger. 15. Any disease particularly conditions that interact with gonadotrophins or their releasing factors and those that compromise digestion or absorption of micronutrients. 16. Any significant health complaint, problem or disease that in the opinion of the researcher would compromise the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by independent researcher
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated; blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 594 0
Commercial sector/Industry
Name [1] 594 0
Swisse Bio-juven
Country [1] 594 0
Primary sponsor type
Commercial sector/Industry
Name
Swisse Bio-juven
Address
Country
Switzerland
Secondary sponsor category [1] 483 0
None
Name [1] 483 0
none
Address [1] 483 0
Country [1] 483 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1689 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 1689 0
Ethics committee country [1] 1689 0
Australia
Date submitted for ethics approval [1] 1689 0
Approval date [1] 1689 0
Ethics approval number [1] 1689 0
Ethics committee name [2] 1690 0
University of Queensland Human research Ethics Committee
Ethics committee address [2] 1690 0
Ethics committee country [2] 1690 0
Australia
Date submitted for ethics approval [2] 1690 0
Approval date [2] 1690 0
Ethics approval number [2] 1690 0

Summary
Brief summary
Calcium and magnesium in the form of a specific mineral supplement will reduce symptoms of premenstrual syndrome by 20% after 4 months of daily use. This calcium and magnesium supplement used in conjunction with a combination of micronutrients in the form of a specific multi vitamin, mineral and herbal tablet will reduce the symptoms of premenstrual syndrome by 30 % after 4 months of daily use.The study also seeks to compare differences in bone densitometry parameters in women with and women without PMS. To achieve this aim 2 cohorts of subjects will be enrolled, Cohort A will be an initial enrolment of 180 women with self-report of PMS. (This number will allow for 30% exclusion due to insufficient premenstrual symptom score at visit 2). Cohort B will be an enrolment of 40 women who do not have PMS after assessment with Menstrual Health Questionnaire (This number will allow for 50% exclusion/drop out at visit 2).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35328 0
Address 35328 0
Country 35328 0
Phone 35328 0
Fax 35328 0
Email 35328 0
Contact person for public queries
Name 9464 0
Professor Stephen Myers
Address 9464 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9464 0
Australia
Phone 9464 0
+61 2 66203403
Fax 9464 0
+61 2 66203307
Email 9464 0
smyers@scu.edu.au
Contact person for scientific queries
Name 392 0
Joan O'Connor
Address 392 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 392 0
Australia
Phone 392 0
+61 2 66203649
Fax 392 0
+61 2 66203307
Email 392 0
joconnor@scu.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.