Determine the effect of Calcium-D supplementation on sugar control of gestational diabetes
Design
A randomized, triple blind clinical trial, based on patients with gestational diabetes, which has two parallel groups.
Settings and conduct
Gestational diabetes is an important complication of pregnancy known as carbohydrate intolerance.Current treatments for gestational diabetes include a carbohydrate-based diet, some blood glucose lowering drugs and insulin therapy.In some studies, the effect of supplementation of calcium alone or in combination with vitamin D in the control and treatment of gestational diabetes has been mentioned. However, these results are contradictory in various studies and it is essential that the effect of this supplement on the control of gestational diabetes is determined.
This study is a randomized controlled clinical trial that doing in Bahar Hospital of Shahroud.
In this study patients, the person responsible for grouping patients and the person in charge of laboratory sampling and prescribing the medicine have been blinded
Participants/Inclusion and exclusion criteria
84 pregnant women suffering to gestational diabetes age limited 18-40 years old who have gestational age of 26 to 24 weeks; have GDM tests positive and have no history of previous glucose control, are included in the study.
Intervention groups
In the intervention group; Calcium-D was used to evaluate its efficacy in gestational diabetes, along with routine gestational diabetes therapy.
In the control group; only routine gestational diabetes therapy has been used.
Main outcome variables
Measurement of blood glucose and glycosylated hemoglobin in the beginning of the study and three months after administration of Calcium-D
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N11
Registration date:2018-09-04, 1397/06/13
Registration timing:registered_while_recruiting
Last update:2018-09-04, 1397/06/13
Update count:0
Registration date
2018-09-04, 1397/06/13
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Calcium-D supplementation effects in sugar control in patients with gestational diabetes
Public title
Calcium-D supplementation effects in sugar control in gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
GDM test positive in 26-24 weeks of pregnancy
Pregnant women without the previous diagnosis of glucose intolerance
Satisfaction in rasarach
Exclusion criteria:
Previous diabetes history
Premature rupture of the membrane
Pausing suddenly of corion
Pregnancy hypertension
Eclampsia
Chronic hypertension
Hypothyroidism
Need to start insulin therapy during the intervention
Dissatisfaction in rasarach
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
84
More than 1 sample in each individual
Number of samples in each individual:
4
Blood glucose and hemoglobin glycosylated samples at the beginning of the study and three months after administration of Calcium-D
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use envelopes in the package
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients, project executives, and person responsible for measuring the sugar test and recording it are blinded.The division of patients into two groups A and B is done by a qualified nurse who has no knowledge of the actions performed in the two groups. Do experiments, drugs Prescribing and results recorder will be done by a qualified nurse without any knowledge of the type of medicine and patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Research Deputy; Shahroud University of Medical Sciences; Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773947
Approval date
2017-05-24, 1396/03/03
Ethics committee reference number
IR.SHMU.REC.1396.41
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Blood glucose measurement
Timepoint
At the beginning of the study and 3 months after starting Calcium-D intake
Method of measurement
Laboratory method of sugar measurement
2
Description
Measuring glycosylated hemoglobin
Timepoint
At the beginning of the study and 3 months after the start of Calcium-D intake
Method of measurement
Laboratory method for glycosylated hemoglobin mesurement
Secondary outcomes
1
Description
Cratenin measurement
Timepoint
At the beginning of the study and 3 months after Calcium-D intake
Method of measurement
laboratory method of Cratenin measurement
2
Description
Urea measurement
Timepoint
At the beginning of the study and 3 months after Calcium-D intake
Method of measurement
laboratory method of urea measurement
Intervention groups
1
Description
Intervention group: for patients in the intervention group; administration of 500 mg of calcium carbonate per day plus 1000 units of vitamin D per day, together with routine gestational diabetes mellitus treatment during the study
Category
Treatment - Drugs
2
Description
Control group: for patients in the control group; only administration of routine gestational diabetes treatment during the study
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar Hospital
Full name of responsible person
ِDr. Mina Sadat Kohbodi
Street address
Bahar Hospital; 22 Bahman Street
City
Shahroud
Province
Semnan
Postal code
3619694668
Phone
+98 23 3224 7653
Fax
+98 23 3224 7653
Email
mina_kohbodi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Research deputy; Shahroud University of Medical Sciences; Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The personal budget of researchers
Proportion provided by this source
90
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Bagher Sohrabi
Position
Educational Manager of Medical Faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 4800
Email
mb.sohrabi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Setare Ghanbari
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossain Hospital; Imam Street
City
Shahroud
Province
Semnan
Postal code
3616651151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
setareh72ghanbari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Setare Ghanbari
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossain Hospital; Imam Street
City
Shahroud
Province
Semnan
Postal code
3616651511
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
setareh72ghanbari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD