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IRCT20180305038958N1 IRCT 2018-08-20 Sabzevar University of Medical Sciences Comparison of initiation of iron supplementation at the end of 4 months and 6 months of age on height, weight and head circumference of infants Comparison of iron supplement effects on neonatal growth indexes, initiated from first 4th and 6th months of life: A randomized clinical trial 2017-04-21 anticipated 100 Complete https://irct.ir/trial/32355 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization based on permutation. Accordingly, 25 blocks were allocated to patients, in each block, 2 from A treatment group and 2 from B treatment group were placed. Eventually, after completion of the blocks, group A was treated with iron drops from 4 months of age and Group B received iron drops at 6 months of age, Blinding description: Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups and the outcome evaluator is unaware of the groups. It should be noted that the participants can not be blinded to the intervention or control group. 3 Infant Growth Index. Intervention 1: Intervention group: Starting an iron ferrous sulfate drop (Iranian Simorgh Darou Attar Company) from the end of 4 months with a dose of 2 mg/kg until the end of 24 months of infancy. Intervention 2: Control group: Starting an iron ferrous sulfate drop (Iranian Simorgh Darou Attar Company) from the 6 months of ages with a dose of 2 mg/kg until the end of 24 months of infancy. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Seyed Mohsen Emami
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4401 1300 Mohsenemami007@gmail.com Sabzevar University of Medical Sciences scientific Seyed Mohsen Emami
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4401 1300 Mohsenemami007@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Infants 4 to 12 months old Gestational age more than 37 weeks Birth weight more than 2500 grams Singleton 4 months 12 months Both Congenital anomalies History of addiction in mother P61.3 Congenital anaemia from fetal blood loss Treatment - Drugs Treatment - Drugs Intervention group: Starting an iron ferrous sulfate drop (Iranian Simorgh Darou Attar Company) from the end of 4 months with a dose of 2 mg/kg until the end of 24 months of infancy Control group: Starting an iron ferrous sulfate drop (Iranian Simorgh Darou Attar Company) from the 6 months of ages with a dose of 2 mg/kg until the end of 24 months of infancy The weight of the infants. Timepoint: Weight measurement at birth and 2, 4, 6, 9 and 12 months. Method of measurement: Baby scales with a capacity of 20 kg with a precision of 20 g to 20 kg. The height of infant. Timepoint: Measuring height at birth and 2, 4, 6, 9 and 12 months. Method of measurement: Meters with millimeter precision. Infant head circumference. Timepoint: Measuring head circumference at birth and 2, 4, 6, 9 and 12 months. Method of measurement: Meters with millimeter precision. Sabzevar University of Medical Sciences Approved 2017-08-15 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar Town Sabzevar Razavi Khorasan Iran (Islamic Republic of)