Clinical trial of comparison of vitamin C and E supplements effect on total antioxidant capacity of healthy women's breast milk in experimental and control groups
In this study, 60 healthy women aged from 20 to 50, along with their 1 to 6-month infants were selected from a Health Center in Birjand. The aim of this study was evaluating the effect of vitamin C and E supplements on the total antioxidant capacity of human’s milk. Exclusion criteria included the formula-feed for the infants and major illnesses (diabetes, infectious diseases, and genetic diseases) of both mothers and infants. Mothers and their infants were divided randomly and alternately into an experimental group and a control group. The mothers in the experimental and control groups were on free diet. Mothers in the experimental group were given 30 effervescent tablets of vitamin C (500 mg) and 30 chewable tablets of vitamin E (100 IU is equal to 100 mg). They should take one tablet from each two kinds of supplements on a daily basis. The control group did not receive this intervention. At the first step, before the intervention, milk samples of right breast of all the mothers in the two groups were taken manually from 9.00 to 11.00 a.m. when the infants were not breast-fed for at least one hour. Urine samples of the infants were collected by standard urine bags. The samples were taken 30 days later again. Total antioxidant capacity of milk and infants’ urine were measured by the FRAP method, and Free radical scavenging activity of the infants’ urine was measured by the DPPH method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072410379N1
Registration date:2013-08-21, 1392/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-21, 1392/05/30
Registrant information
Name
Asghar Zarban
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 0388
Email address
azarban@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of vitamin C and E supplements effect on total antioxidant capacity of healthy women's breast milk in experimental and control groups
Public title
Effect of vitamin C and E supplements on mother's milk
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having 1 to 6 months of age infants who were exclusively breast-fed since birth
Exclusion criteria: formula-feed for the infants, and/or major illnesses (diabetes, infectious diseases, and genetic diseases) of mothers or the infants
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, mothers were the criterion for randomization, and infants were placed in the similar group of their mothers after randomizing the mothers. The first mother and her infant were randomly placed in one of the two groups, either the experimental group or the control group, by selecting a card from two cards on which were written the terms "control" and "experimental". The other mothers together with their infants were assigned to the two groups alternately. Mothers in the experimental group were given 30 effervescent tablets of vitamin C and 30 chewable tablets of vitamin E. They should take one tablet from each two kinds of supplements on a daily basis. The control group did not receive any intervention. It is noteworthy that the mothers in the experimental and control groups were on free diet. The measurement of the antioxidant indices in infants’ urine was only done with the aim of a better evaluation of the intervention effect on the antioxidant capacity of mothers’ milk.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Shahid Ghaffari St., Birjand, Southern Khorasan
City
Birjand
Postal code
Approval date
2009-02-11, 1387/11/23
Ethics committee reference number
12/73150
Health conditions studied
1
Description of health condition studied
Effect of supplements on total antioxidant capacity of human breast milk
ICD-10 code
Z39.1
ICD-10 code description
Care and examination of lactating mother
Primary outcomes
1
Description
Total antioxidant capacity of human breast milk
Timepoint
Before the intervention and 30 days after the intervention
Method of measurement
FRAP method
Secondary outcomes
1
Description
Urine antioxidant capacity of the infants and free radical scavenging activity of the infants' urine
Timepoint
Before the intervention and 30 days after the intervention
Method of measurement
FRAP, DPPH methods
Intervention groups
1
Description
Mothers in the experimental group: 30 effervescent tablets of vitamin C (500 mg) and 30 chewable tablets of vitamin E (100 IU is equal to 100 mg) were given to them, and they should take one tablet from each two kinds of supplements on a daily basis.
Mothers in the control group: They received no intervention and were on free diet.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand Health Center (Number 3)
Full name of responsible person
Khalil Balali Mood
Street address
Birjand Health Center (Number 3), 5th Alley, Shahid Bargi St., Azadi Square, Birjand, Southern Khorasan
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Birjand University of Medical Sciences
Full name of responsible person
Asghar Zarban
Street address
Birjand University of Medical Sciences, Shahid Ghaffari St., Birjand, Southern Khorasan
City
Birjand
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, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Asghar Zarban
Position
PhD biochemistry/ Associate professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Shahid Ghaffari St., Birjand, Southern Khorasan
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
Email
azarban@yahoo.com ; azarban@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Asghar Zarban
Position
Biochemistry PhD
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Shahid Ghaffari St., Birjand, Southern Khorasan
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
Email
azarban@yahoo.com ; azarban@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Asghar Zarban
Position
Biochemistry PhD/ Associate professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Shahid Ghaffari St., Birjand, Southern Khorasan
City
Birjand
Postal code
Phone
+98 56 1444 3041
Fax
Email
azarban@yahoo.com ; azarban@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)