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IRCT20091114002709N47 IRCT 2018-03-11 Iran University of Medical Sciences The effect of vitamin C supplementation in the last month of pregnancy on neonatal bilirubin level The effect of vitamin C supplementation in the last month of pregnancy on neonatal bilirubin level 2018-05-22 anticipated 144 Complete https://irct.ir/trial/29509 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: For randomization, the permuted block randomization method will be used with quadruple blocks. Based on the sample size of 144, 36 blocks will be produced using the online site www.sealedenvelope.com. In order to apply the concealment in the randomization process, unique code will be used on the drug boxes, the code being generated by the software. By entering each individual into a study based on the generated sequence, the pack of the drug in which the code is registered will be assigned to the individual, Blinding description: Neither our (researcher nor statistician) nor the participants will know which complement or placebo are used (a triple blind study). N/A Jaundice of infants. Intervention 1: Intervention group: Use 500 mg Vitamin C supplement /manufactured by Oswah Pharmaceutical Company / Daily / From the beginning of the 35th week to the end of pregnancy. Intervention 2: Control group: Use of placebo made from starch / manufactured by Oswah Pharmaceutical Company / Daily / From the beginning of the 35th week to the end of pregnancy. Yes - There is a plan to make this available What will be shared: In this study, after being unidentified, there is no limit to the disclosure of information When: 6 months after the end of the study To whom: There is no limit Conditions: In order to develop relevant studies Keep your trust and mention the source Where to obtain: m.khadem.nut@gmail.com How to obtain: Upon receipt of requests and reviews, documentats will be provided within a maximum of one month. Comments:
public Farzad Shidfar
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad Shidfar
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Being on the 34th week of pregnancy Single pregnancy Willingness to participate in research and signing consent Age range 20 to 40 years 20 years 40 years Female pregnancy-related illnesses such as gestational diabetes, gestational hypertension, or hypothyroidism in pregnancy Having severe anemia Hepatic Diseases Renal diseases birth history of premature and low birth weight Family history of favism lactation at the same time as pregnancy use of aspirin and anticoagulants smoking P59.9 Neonatal jaundice, unspecified Prevention Prevention Intervention group: Use 500 mg Vitamin C supplement /manufactured by Oswah Pharmaceutical Company / Daily / From the beginning of the 35th week to the end of pregnancy. Control group: Use of placebo made from starch / manufactured by Oswah Pharmaceutical Company / Daily / From the beginning of the 35th week to the end of pregnancy Neonatal blood bilirubin level. Timepoint: Fifth day after birth. Method of measurement: A blood sample of the heel is used to determine the level of bilirubin. This test will be based on light irradiation and turbodometry. Iran University of Medical Sciences Approved 2018-01-30 Ethics Committee of Iran University of Medical Sciences Hemmat Highway, next to Milad Tower Tehran Tehran Iran (Islamic Republic of)