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IRCT2016090329675N1 IRCT 2016-09-25 Vice chancellor for research, Shahid Beheshti University of Medical Sciences, School of Nutrition an Effect of vitamin D supplementation on the pregnancy outcomes Evaluation the efficacy of vitamin D supplementation during pregnancy on maternal and newborn vitamin D status and pregnancy outcomes compared with control group 2016-10-11 anticipated 126 Complete https://irct.ir/trial/23794 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Considering the inclusion and exclusion criteria, pregnant women will participate in this study, then participants are randomly attributed to three groups including two intervention groups and one control group using Random-number table. 2-3 Condition 1: Pre-eclampsia. Condition 2: Vitamin D status in pregnant women and cord blood. Condition 3: Getational Diabetes Mellitus. Condition 4: Preterm delivery. Condition 5: Abortion. Intervention 1: Control group: Current supplementation during pregnancy (Iron, Folic acid, Multi-vitamin). Intervention 2: Intervention group 1: Current supplementation during pregnancy (Iron, Folic acid, Multi-vitamin) + 1000 IU/d vitamin D. Intervention 3: Intervention group 2: Current supplementation during pregnancy (Iron, Folic acid, Multi-vitamin) + 2000 IU/d vitamin D.
public Soudabe Motamed
No.7, Hafezi St., Farahzadi Blvd., Shahrak Qods (Gharb), Tehran, Iran
Tehran Iran (Islamic Republic of) 198161957 +98 21 2237 6471 s_motamed@sbmu.ac.ir; smotamed2010@gmail.com National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Te scientific Tirang Neyestani
No. 7, Hafezi St., Farahzadi Blvd., Shahrak Qods (Gharb), Tehran, Iran
Tehran Iran (Islamic Republic of) 198161957 +98 21 2237 6471 neytr@yahoo.com Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research Inst Iran (Islamic Republic of) Inclusion criteria: Pregnant women aged at 18-40 years and their newborns, Singleton pregnancy. Exclusion criteria: Multiple pregnancy, Diagnosis any kind of diseases including renal, hepatic, and other disorders which could influence vitamin D metabolism during the study, Chronic hypertension, Receiving vitamin D or calcium supplements within the last three months, On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months, Newborns with congenital anomalies. 18 years 40 years Female O14.9 E55 O24.4 O60 O60 Pre-eclampsia, unspecified E55: Vitamin D deficiency Diabetes mellitus arising in pregnancy (Gestational diabetes mellitus NOS) Preterm labour and delivery Spontaneous abortion Prevention Prevention Prevention Control group: Current supplementation during pregnancy (Iron, Folic acid, Multi-vitamin) Intervention group 1: Current supplementation during pregnancy (Iron, Folic acid, Multi-vitamin) + 1000 IU/d vitamin D Intervention group 2: Current supplementation during pregnancy (Iron, Folic acid, Multi-vitamin) + 2000 IU/d vitamin D Vitamin D concentration of pregnant women serum. Timepoint: Baseline and after the intervention. Method of measurement: High performance liquid chromatography (HPLC). Vitamin D concentration of Cord blood. Timepoint: At birth. Method of measurement: High performance liquid chromatography (HPLC). Growth indices of newborns. Timepoint: After Birth. Method of measurement: Infant's Records. Preterm delivery. Timepoint: At less than 37 weeks of gestational age. Method of measurement: Pregnant women Records. Abortion. Timepoint: During the first 28 weeks of pregnancy. Method of measurement: Pregnant women Records. Gestational diabetes. Timepoint: At the gestational age of 24-28 weeks. Method of measurement: Pregnant women Records. Preeclampsia. Timepoint: At the gestational age of 24-28 weeks. Method of measurement: Pregnant women Records. no registeration no registeration no registeration no registeration Vice chancellor for research, Shahid Beheshti University of Medical Sciences, School of Nutrition an Approved 2016-01-17 Ethics committee of International Branch of Shahid Behesti University of Medical Sciences and Health No. 19, Shahid abbaspour St., vali-asr Av., Tehran, Iran. Tehran Iran (Islamic Republic of)