Condition category
Urological and Genital Diseases
Date applied
02/06/2005
Date assigned
21/09/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joan O'Connor

ORCID ID

Contact details

P.O. Box 157
Lismore
2480
Australia
+61 (0)2 66 20 3649
joconnor@scu.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ECN-04-208

Study information

Scientific title

Acronym

PMS study

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Pre-menstrual syndrome

Intervention

The active group is taking calcium and magnesium, and a multivitamin and mineral supplement and control will take 2 placebo tablets; one will be the same size and shape as the calcium and magnesium supplement, and the second will be the same size and shape as the multivitamin and mineral supplement and contain sufficient riboflavin to maintain blinding.

Intervention type

Supplement

Phase

Not Specified

Drug names

Calcium, magnesium, multi vitamin, mineral and herbal

Primary outcome measures

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 – 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. Subjects will record these details in a daily diary.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2004

Overall trial end date

30/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject has a regular menstrual cycle of 25 to 35 days
2. Subject is aged over 18 and less than 45 years
3. Subject’s general health is normal
4. Subject has had symptoms of PMS in the last year
5. Subject is willing to cease taking other supplements for the period of the trial
6. Subject is willing to comply with the study protocol

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120 women in cohort A and 20 women in cohort B

Participant exclusion criteria

1. Subject is currently pregnant or lactating
2. Subject who is of childbearing age who is not surgically sterile, who is:
a. Not using effective contraception
b. 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

Recruitment start date

01/09/2004

Recruitment end date

30/10/2005

Locations

Countries of recruitment

Australia

Trial participating centre

P.O. Box 157
Lismore
2480
Australia

Sponsor information

Organisation

Swisse Vitamins Pty Ltd (Australia)

Sponsor details

36-38 Gipps Street
Collingwood
Melbourne
3066
Australia

Sponsor type

Industry

Website

http://www.swisse.com.au

Funders

Funder type

Industry

Funder name

Swisse Vitamins Pty Ltd (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes