The effects of nutritional supplementation on premenstrual syndrome (PMS)

ISRCTN	ISRCTN48058420
DOI	https://doi.org/10.1186/ISRCTN48058420
Protocol serial number	ECN-04-208
Sponsor	Swisse Vitamins Pty Ltd (Australia)
Funder	Swisse Vitamins Pty Ltd (Australia)

Submission date: 02/06/2005
Registration date: 21/09/2005
Last edited: 14/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Joan O'Connor
Scientific

P.O. Box 157
Lismore
2480
Australia

Phone	+61 (0)2 66 20 3649
Email	joconnor@scu.edu.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PMS study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/10/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	140
Key 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. Subjects 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
Key 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
Date of first enrolment	01/09/2004
Date of final enrolment	30/10/2005

Locations

Countries of recruitment

Australia

Study participating centre

P.O. Box 157

Lismore
2480
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan