1. Home
  2. Approved trials
  3. » فارسی

Effect of jujube consumption on heavy metal levels (Pb, As, Cd) of breast milk in lactating women

Protocol summary

Summary
This parallel randomized clinical trial will be conducted to determine the effect of jujube consumption on heavy metal levels (Pb, As, Cd) of breast milk in lactating women. The study participants included 40 breast-feeding women after postpartum who were randomly divided into two groups of (20 persons in each group), intervention and control. The sampling method is convenient and consecutive. Inclusion criteria are no history of chronic disease of mother, no smoking, no history of medication, residence in the city of Isfahan and written informed consent. Exclusion criteria will be no access to lactating-mothers in order to provide the breast milk after 2 month, no continuation of breastfeeding up to two month after delivery, any chronic disease incidence or drug usage during the study. Immediately after the child birth and breast milk flow, a sample of breast milk (10 cc) will be collected to determine the heavy metal levels (Pb, As, Cd as the main outcome variables). Intervention group will receive 15 g/day (once per day) Jujube for two months. Control group will not receive any placebo. After two months intervention, 10 cc of breast milk of each group of intervention and control, will be collected to measure the levels of Pb, As and Cd. To analyze the data, SPSS version 20, Independent T test and Paired T test will be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302061434N8
Registration date: 2013-12-09, 1392/09/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-09, 1392/09/18
Registrant information
Name
Roya Kelishadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 3060
Email address
kelishadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-06-12, 1391/03/23
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of jujube consumption on heavy metal levels (Pb, As, Cd) of breast milk in lactating women
Public title
Effect of jujube consumption on heavy metal levels (Pb, As, Cd) of breast milk in lactating women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no history of chronic disease of mother; no smoking; no history of medication; residence in the city of Isfahan (being residence in Isfahan at least from the last year) and written informed consent. Exclusion criteria: no access to lactating-mothers in order to provide the breast milk after 2 month; no continuation of breastfeeding up to two month after delivery; any chronic disease incidence or drug usage during the study.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Jujube is similar to dates, consists of maslinic acid, oleanolic acid, betulinic acid, glucose, resin, stigmasterol, sitosterol, tannin, essential fatty acids, 13 kinds of amino acids, selenium, cadmium, phosphorus and iron.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St.
City
Isfahan
Postal code
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
391142

Health conditions studied

1

Description of health condition studied
elevated levels of heavy metals in breast milk
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Lead
Timepoint
at baseline and at the end of study (after 2 months intervention)
Method of measurement
µg ̸ lit Lab Kit

2

Description
Arsenic
Timepoint
at baseline and at the end of study (after 2 months intervention)
Method of measurement
µg ̸ lit lab kit

3

Description
Cadmium
Timepoint
at baseline and at the end of study (after 2 months intervention)
Method of measurement
µg ̸ lit lab kit

Secondary outcomes

empty

Intervention groups

1

Description
Jujube / day, 15 mg / oral / 2 months / for intervention group
Category
Treatment - Drugs

2

Description
Control group will not recieve placebo.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Najmeh Hasanghalyaei
Street address
Esfahan-Motahari st
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Peyman Adibi
Street address
Hezar Jarib St.
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Najmeh Hasanghalyaei
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
HezarJarib St.
City
Isfahan
Postal code
Phone
+98 31 1668 0048
Fax
Email
najmeh2791@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Roya Kelishadi
Position
Pediatrics
Other areas of specialty/work
Street address
Hezar Jarib St.
City
Isfahan
Postal code
Phone
+98 31 1668 0048
Fax
Email
kelishadi@ med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Najmeh Hasanghalyaei
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Hezar Jarib St.
City
Isfahan
Postal code
Phone
+98 31 1668 0048
Fax
Email
najmeh2791@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...