Objective: This study is to determine the effects of multivitamin, multivitamin-mineral and probiotic Gaz supplementation on pregnancy outcomes. Study design: Randomized double-blind controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women, primigravida, aged 18-40 year old who were carrying singleton pregnancy at their second and third trimester will be included in this study. Multiparous women as well as those with hypertension, gestational diabetes mellitus (GDM), complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 200 pregnant women of eligible and referred to Naghavi clinic in Kashan, in the study will be selected. Individuals will be divided to 6 groups (3 groups intervention and 3 groups control). Intervention: Subjects will be assigned to receive multivitamin-mineral, calcium-vitamin D3 supplements and probiotic Gaz (intervention groups) or multivitamin supplements, placebo and normal Gaz (control groups). Fasting blood samples will be taken at baseline and after 20-wk intervention to measure metabolic profiles and biomarkers of oxidative stress. Start and End Date of Intervention: 20 weeks (June 21, 2012-November 21, 2012). Outcomes: Baseline and End-of-trial serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides levels, fasting plasma glucose (FPG), serum calcium, iron, zinc levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212105623N3
Registration date:2012-12-26, 1391/10/06
Registration timing:retrospective
Last update:
Update count:1
Registration date
2012-12-26, 1391/10/06
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of multivitamin, multivitamin-mineral supplements, probiotic and normal Gaz on pregnancy outcomes in pregnant women
Public title
Effects of supplementation in treatment of pregnancy complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women; primigravida; aged 18-40 year old who were carrying singleton pregnancy at their second and third trimester. Exclusion Criteria: Multiparous women; patients with hypertension; gestational diabetes mellitus (GDM); complete bed rest (CBR); intra uterine fetal death (IUFD); placenta abruption; preterm delivery.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ravandi ghotbe avenue, Kashan
City
Kashan
Postal code
Approval date
2011-08-09, 1390/05/18
Ethics committee reference number
29/5/1/1384/پ
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
094
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Fasting glucose plasma
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Total cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
3
Description
HDL-Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
4
Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
5
Description
plasma total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
6
Description
Total glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Multivitamin-mineral supplements consisted of 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, 125 mg calcium, 18 mg iron, 100 mg magnesium, daily for 20 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Probiotic Gaz consisted of Lactobacillus acidophilus 107 CFU/g, 20 g, twice a day for 8 weeks
Category
Treatment - Other
3
Description
Control group: Multivitamin supplements consisted of 5000 IU vitamin A, 15 IU vitamin E, 400 IU vitamin D3, 1.5 mg vitamin B1, 1.7 mg vitamin B2, 20 mg niacin, 2 mg vitamin B6, 400 µg folic acid, 6 µg vitamin B12, 60 mg vitamin C, daily for 20 weeks
Category
Treatment - Drugs
4
Description
Control group: Normal Gaz, 20 g, twice a day for 8 weeks
Category
Other
5
Description
Added at 2013-06-26: Intervention group: Calcium-vitamin D3 capsule, 500mg calcium-200 IU vitamin D3, for 9 weeks orally.
Category
Treatment - Drugs
6
Description
Added at 2013-06-26: Control group: Placebo capsule, for 9 weeks orally
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University Of Medical Science
Full name of responsible person
Zatollah Asemi
Street address
Ravandi ghotbe Avenue, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University Of Medical Science
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Sekkeh Gaz
Full name of responsible person
Dr Goharian
Street address
Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sekkeh Gaz
Proportion provided by this source
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University Of Medical Science
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Ravandi ghotbe Avenue, Kashan
City
Kashan
Postal code
8719844189
Phone
+98 36 1446 3378
Fax
+98 36 1446 3377
Email
asemi_z@kaums.ac.irasemi_za@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Other areas of specialty/work
Street address
Ravandi ghotbe Avenue, Kashan
City
Kashan
Postal code
8719844189
Phone
+98 36 1446 3378
Fax
+98 36 1446 3377
Email
asemi_z@kaums.ac.irasemi_za@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)