Comparative study of Calcium efficacy and placebo on leg muscle cramps during pregnancy in patients referred to clinics supervised by Bushehr University of Medical Sciences
The aim of this randomized, double blind, placebo- controlled, phase 2, multicenter study is to evaluate calcium efficacy on leg muscle cramps. A total of 60 pregnant women suffering from leg cramps who sought medical treatment in three selected clinics in Bushehr were allocated into intervention or control study to receive calcium, 500mg daily for four weeks or placebo. The number and intensity of muscle cramps were evaluated and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009274824N1
Registration date:2011-02-05, 1389/11/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-05, 1389/11/16
Registrant information
Name
Rozita Khoramrodi
Name of organization / entity
School Of Nursing & Midwifery, Bushehr University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
r.khoramrodi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Managment Affairs, Bushehr University Of Medical Sciences
Expected recruitment start date
2006-03-21, 1385/01/01
Expected recruitment end date
2007-11-18, 1386/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of Calcium efficacy and placebo on leg muscle cramps during pregnancy in patients referred to clinics supervised by Bushehr University of Medical Sciences
Public title
Comparative study of Calcium efficacy and placebo on leg muscle cramps during pregnancy in patients referred to clinics supervised by Bushehr University of Medical Sciences
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: third trimester of pregnancy, single pregnancy, no consumption of any drug excepts for Iron and multivitamins
Exclusion criteria: Irregular use of medication, PLP, unwilling to complete forms
Age
From 16 years old to 39 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University Of Medical Sciences
Street address
Reshehr, Sabz Abad, Bushehr
City
Bushehr
Postal code
Approval date
2006-02-28, 1384/12/09
Ethics committee reference number
2154/3/18/20/دپ
Health conditions studied
1
Description of health condition studied
leg cramp
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Leg Cramp
Timepoint
Seven days before until the end of the intervention
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 1 Placebo capsule (lactose Merk) daily for four weeks
Category
Placebo
2
Description
Intervention group: 500mg calcium, daily for four weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center Haftom Tir
Full name of responsible person
Farzaneh Noroozi- Bachelor of midwifery
Street address
Bushehr- Imam khomeini street- Boostan 19 Alley
City
BUSHEHR
2
Recruitment center
Name of recruitment center
Health center - Ali Ebn Abi Taleb
Full name of responsible person
Mahmanzar Barmshoori
Street address
Deputy for health, Bushehr University of Medical Sciences
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Managment Affairs, Bushehr University Of Medical Sciences
Full name of responsible person
Maryam Ravanipour
Street address
Bushehr University Of Medical Sciences, Reshehr, Sabzabad, Bushehr
City
Bushehr University Of Medical Science
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Managment Affairs, Bushehr University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Bushehr University of Medical Sciences
Full name of responsible person
Rozita Khoramrodi
Position
Master Of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bushehr University of Medical Sciences, Reshehr, Sabzabad
City
Bushehr
Postal code
Phone
+98 77 1455 0187
Fax
Email
r.khoramrodi@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Bushehr University of Medical Sciences
Full name of responsible person
Rozita khoramrodi
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bushehr University Of Medical Sciences, Reshehr, Sabzabad
City
Bushehr
Postal code
Phone
+98 77 1455 0187
Fax
Email
r.khoramrodi@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr university Of Medical Sciences- School Of Nur sing and Midwifery
Full name of responsible person
Rozita Khoramrodi
Position
Master of midwifery/ coach
Other areas of specialty/work
Street address
Reshehr- Sabzabad-School Of Nursing and Midwifery
City
Bushehr
Postal code
Phone
+98 77 1455 0187
Fax
+98 77 1455 0187
Email
r.khoramrodi@bpums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)