Evaluation of the effects of two dose of iodine supplements on lactating mothers’ and breast-fed infants’ iodine nutrition status and comparing to formula-fed infants: From birth to one year
Objective: Evaluation of the effects of two dose of iodine supplements on lacatating mothers’ and breast-fed infants’ iodine nutrition status and comparing to formula-fed infants Design: Multicentre clinical trial Methods: A- subjects- Major inclusion criteria: Lactating mothers, breast-fed and formula-fed infants- Major exclusion criteria: Thyroid diseases in mothers and hypothyroidism in neonates -Sample size: 208 B-intervention: Supplements containing 150 and 300 micrograms iodine C- Intervention time: Assessment of breast milk iodine and urinary iodine concentration in mothers and infants in 3-5 days, 1, 2, 4, 6, 9, 12 months D- Main outcome: breast milk iodine and urinary iodine concentrations
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303164794N8
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
Research Institute for Endocrine Science, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of two dose of iodine supplements on lactating mothers’ and breast-fed infants’ iodine nutrition status and comparing to formula-fed infants: From birth to one year
Public title
Iodine supplementation and iodine nutrition in lactating mothers and their breast-fed infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: lactating mother; full-term infants (37-42 weeks) with normal birth weight (2500-4200 g); neonate with age 3-5 days
Exclusion criteria:Thyroid diseases in lactating mothers and their infants; Taking thyroid medications; using self-order iodine containing supplements; using iodinated antiseptics; 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:
208
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
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 S