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Evaluation of the effects of iodine fortified-milk on lactating mothers’ and their infants’ iodine nutrition status

Protocol summary

Summary
Objective: Evaluation of the effects of iodine fortified-milk on lactating mothers’ and their infants’ iodine nutrition status. Design: Multicenter clinical trial. Setting and conduct: A-Participants including major eligibility criteria- Major inclusion criteria: Lactating mothers and their infants Major exclusion criteria: Thyroid diseases in mothers and their infants, neonate hypothyroidism- Sample size:52 B- Intervention: Iodine-enriched milk C-Intervention time: 3-5, 7, 10,14 days and 1, 2 months after delivery D-Main outcome: Breast milk and urinary iodine concentrations

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305074794N9
Registration date: 2013-05-20, 1392/02/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-05-20, 1392/02/30
Registrant information
Name
Fereidoun Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 9309
Email address
azizi@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of iodine fortified-milk on lactating mothers’ and their infants’ iodine nutrition status
Public title
Iodine fortified-milk and iodine nutrition in lactating mothers and their infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Lactating mothers; full-term infants(37-42 weeks) with normal birth weight (2500-4200 g); neonates with age 3-5 days. Exclusion criteria: Having thyroid diseases; taking anti- thyroid medications; using iodine containing supplements; neonate hypothyroidism
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthics Committee, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical
Street address
No. 24, Shahid Aerabi St., Yemen St., Chamran Exp.
City
Tehran
Postal code
Approval date
2013-02-26, 1391/12/08
Ethics committee reference number
23ECRIES

Health conditions studied

1

Description of health condition studied
iodine deficiency
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Urinary iodine concentration in breast milk-fed infants
Timepoint
3-5, 7, 10, 14 days, 1, and 2 months after birth
Method of measurement
Acid- Digestion

Secondary outcomes

1

Description
Urinary iodine concentration in lactating mothers
Timepoint
3-5, 7, 10, and 14 days, 1 and 2 months after delivery
Method of measurement
Acid Digestion

2

Description
Breast milk iodine concentration
Timepoint
3-5, 7, 10, and 14 days, 1 and 2 months after delivery
Method of measurement
Acid Digestion

Intervention groups

1

Description
Intervention Group: Iodine fortified-milk
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Care Centers in the south of Tehran
Full name of responsible person
Expert in mother's and child's health
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical
Full name of responsible person
Prof. Fereidoun Azizi
Street address
No. 24, Shahid Aerabi St., Yemen St., Chamran Exp.
City
Tehran
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 Institute for Endocrine Sciences, Shahid Beheshti University of Medical
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
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Prof. Fereidoun Azizi
Position
Professor, Professor of internal medicine and endocrinology/ Director of Research Institute for Endo
Other areas of specialty/work
Street address
No. 24, Shahid Aerabi St., Yemen St., Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
azizi@endocrine.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Prof. Fereidoun Azizi
Position
Professor, Professor of internal medicine and endocrinology/ Director of Research Institute for Endo
Other areas of specialty/work
Street address
No. 24, Shahid Aerabi St., Yemen St., Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
azizi@endocrine.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid beheshti
Full name of responsible person
Pantea Nazeri
Position
PhD by Research student, MSc in Nutrition Sciences/ Researcher
Other areas of specialty/work
Street address
No. 24, Shahid Aerabi St.,Yemen St., Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
nazeri.pantea@gmail.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
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