Oral magnesium for relief in pregnancy-induced leg cramps
| ISRCTN | ISRCTN03989660 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03989660 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/11/2011
- Registration date
- 14/11/2011
- Last edited
- 22/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Scientific
Department of Obstetrics and Gynecology
Faculty of Medicine
Chulalongkorn University
Rama IV Road
Pathumwan
Bangkok
10330
Thailand
| vorapong.p@chula.ac.th |
Study information
| Study design | Randomized double-blinded placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomized, double-blinded, placebo-controlled trial of oral magnesium for relief in pregnancy-induced leg cramps |
| Study hypothesis | Oral magnesium can relieve pregnancy-induced leg cramps when compare to placebo |
| Ethics approval(s) | Institutional Review Board, Faculty of Medicine, Chulalongkorn University, 17/06/2010, ref: 005/53 |
| 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 |
| Primary outcome measure | 50% reduction in frequency of leg cramps |
| Secondary outcome measures | 1. 50% reduction of cramp intensity 2. Side effects |
| Overall study start date | 01/06/2010 |
| Overall study end date | 31/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 86 |
| 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 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
Study participating centre
10330
Thailand
Sponsor information
University/education
Faculty of Medicine
Rama IV Road
Pathumwan
Bangkok
10330
Thailand
| Website | http://www.chula.ac.th/cuen/ |
|---|---|
"ROR" |
https://ror.org/028wp3y58 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- จุฬาลงกรณ์มหาวิทยาลัย, CU, Chula
- Location
- Thailand
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
22/09/2016: Plain English summary added.
