Condition category
Pregnancy and Childbirth
Date applied
08/11/2011
Date assigned
14/11/2011
Last edited
22/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Leg cramps are common for pregnant women; 30-45% of pregnant women suffer from leg cramps. Pregnancy-induced leg cramp tends to be more frequent during the second half of pregnancy, and mostly at night, resulting in sleep disruption which potentially introduces other complications. Currently, there is no standard treatment for pregnancy-induced leg cramps; however several studies have been conducted so far. Magnesium seems to be beneficial in the treatment of pregnancy-induced leg cramps. Shortage of magnesium may be why there is a higher rate of leg cramps in pregnancy. There have been few studies of magnesium for the treatment of leg cramps in pregnancy. The aim of this study is to assess the effectiveness of magnesium biglycinate chelate as a treatment for pregnancy-induced leg cramps.

Who can participate?
Pregnant women who have pregnancy-induced leg cramps at least twice a week

What does the study involve?
Participants are asked about their leg cramps and background characteristics such as age, income, education, standing or walking hours per day, BMI before pregnancy, antenatal supplement drugs, calcium supplement, blood pressure, leg edema (swelling) and varicose veins. After that participants are randomly allocated to receive either magnesium biglycinate chelate tablets or a placebo (dummy) supplement. Participants take one tablet, three times a day with a meal. The duration of treatment was 4 weeks. At the follow-up participants are asked about their leg cramps and side effects such as nausea, vomiting and diarrhea are recorded.

What are the possible benefits and risks of participating?
There may be mild nausea and diarrhea while taking the medication.

Where is the study run from?
Chulalongkorn University (Thailand)

When is the study starting and how long is it expected to run for?
June 2010 to August 2011

Who is funding the study?
Chulalongkorn University (Thailand)

Who is the main contact?
Dr Vorapong Phupong
vorapong.p@chula.ac.th

Trial website

Contact information

Type

Scientific

Primary contact

Prof Vorapong Phupong

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Faculty of Medicine
Chulalongkorn University
Rama IV Road
Pathumwan
Bangkok
10330
Thailand
-
vorapong.p@chula.ac.th

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized, double-blinded, placebo-controlled trial of oral magnesium for relief in pregnancy-induced leg cramps

Acronym

Study hypothesis

Oral magnesium can relieve pregnancy-induced leg cramps when compare to placebo

Ethics approval

Institutional Review Board, Faculty of Medicine, Chulalongkorn University, 17/06/2010, ref: 005/53

Study design

Randomized double-blinded placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Pregnant women with leg cramps

Intervention

Oral magnesium biglycinate chelate (300mg/day) versus placebo

Total duration of interventions is 4 weeks. Study drugs either magnesium or placebo will be administered orally at a frequency of three times a day for 4 weeks. Participants complete the follow-up case report forms (CRF) at the beginning of the 4th week and completed it at the end of the 4th week. For the follow-up CRF, leg cramps characteristics and side effects such as nausea, vomiting and diarrhea were recorded. Participants return follow-up CRF and the plastic container at the end of the 4th week.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

50% reduction in frequency of leg cramps

Secondary outcome measures

1. 50% reduction of cramp intensity
2. Side effects

Overall trial start date

01/06/2010

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women were those with 14-34 weeks of gestation
2. Having pregnancy-induced leg cramps at least twice a week
3. No other medical disease
4. No concurrent obstetrics complication
5. No other prescriptions for leg cramps
6. No history of magnesium allergy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

86

Participant exclusion criteria

1. Pregnant women with multifetal gestation
2. Subsequently developed pregnancy-induced hypertension and preterm labor treated with tocolytic agent

Recruitment start date

01/06/2010

Recruitment end date

31/08/2011

Locations

Countries of recruitment

Thailand

Trial participating centre

Chulalongkorn University
Bangkok
10330
Thailand

Sponsor information

Organisation

Chulalongkorn University (Thailand)

Sponsor details

Faculty of Medicine
Rama IV Road
Pathumwan
Bangkok
10330
Thailand

Sponsor type

University/education

Website

http://www.chula.ac.th/cuen/

Funders

Funder type

University/education

Funder name

Chulalongkorn University (Thailand)

Alternative name(s)

CU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Thailand

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

22/09/2016: Plain English summary added.