Objectives: This study aims to determine the effect of Vitamin D and calcium plus vitamin D for leg cramps in pregnant women.
Design: Triple blind Randomized Controlled Trial.
Setting and conduct: This study will be conducted in Tabriz health centers. Eligible women will be selected with convenience sampling and will be randomly assigned into 3 groups of 42 subjects with block sizes of 3 and 6. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants: 126 pregnant women aged 18 to 35 years with gestational age of 25 to 30 weeks who have at least two leg cramps per week.
Interventions: The number, severity and duration of leg cramps will be measured daily during a week before the start of the intervention. After completing the basic information and Pittsburgh sleep quality questionnaire, one intervention group will receive Vitamin D tablets (1000 units) and the other intervention group will receive calcium-vitamin D tablets (300mg calcium carbonat plus 1000 units vitamin D). The control group will receive placebo.
Main outcome measures: Number and duration of leg cramps will be evaluated by the checklist and its severity will be assessed by VAS scale before, 4 and 8 weeks after the intervention. Secondary outcomes include sleep quality, delivery characteristics and anthropometric indicators that will be respectively assessed by Pittsburgh sleep quality index before and 8 weeks after the intervention and checklist after delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040810324N12
Registration date:2013-05-04, 1392/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-04, 1392/02/14
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-30, 1392/02/10
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin D and calcium plus vitamin D for leg cramps in pregnant women: A randomised controlled trial
Public title
The effect of Vitamin D and calcium plus vitamin D for leg cramps in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with gestational age of 25-30 weeks aged 18 to 35 years old; having Leg cramps at least twice a week; being literate.
Exclusion criteria: Having known thyroid, cardio-vascular, diabetes or renal diseases; intake of calcium and vitamin D supplementation during pregnancy; having allergy history to studied drugs.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
00984113357311
Approval date
2013-03-14, 1391/12/24
Ethics committee reference number
91230
Health conditions studied
1
Description of health condition studied
Leg cramps in pregnant women
ICD-10 code
O26.8
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
The number of leg cramps
Timepoint
Before interventions, 4 and 8 weeks after intervention
Method of measurement
Daily counts
2
Description
Severity of leg cramps
Timepoint
Before interventions, 4 and 8 weeks after intervention
Method of measurement
Visual Analog Scale (VAS)
3
Description
Duration of leg cramps
Timepoint
Before intervention, 4 and 8 weeks after intervention
Method of measurement
According to minute
Secondary outcomes
1
Description
Sleep quality scores
Timepoint
Before and after intervention
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Anthropometric indices
Timepoint
After delivery
Method of measurement
Newborn growth monitoring form
3
Description
Preterm labor
Timepoint
after delivery
Method of measurement
Frequency
4
Description
Cesarean delivery
Timepoint
After delivery
Method of measurement
Frequency
Intervention groups
1
Description
The first intervention group will receive1000 units vitamin D daily for 60 days.
Category
Treatment - Drugs
2
Description
The second intervention group will receive 300 mg carbonate calcium plus 1000 units vitamin D daily for 60 days.
Category
Treatment - Drugs
3
Description
The control group will receive 500 mg placebo tablet daily for 60 days. Placebo tablets contain avisel, lactose and starch.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz health centers
Full name of responsible person
Mansouri Ameneh
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Shakouri Seyyed Kazem
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Mansouri Ameneh
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
66156-15733
Phone
+98 26 3456 3396
Fax
-
Email
amene_mansouri66@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mozhgan Mirghafourvand
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
347-51745
Phone
+98 41 1479 6770
Fax
-
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)