]>
IRCT2014102519660N1 IRCT 2015-01-22 Medical Sciences for Research of Shahid Beheshti Medical university Comparison the Effectiveness of different Prescription Method of Vitamin D3 on Obstetric and Early Neonatal Outcomes in Pregnant Women with Vitamin D deficiency. Effectiveness of different Prescription Method of Vitamin D3 on Obstetric and Early Neonatal Outcomes in Pregnant Women with Vitamin D deficiency 2014-12-01 anticipated 800 Complete https://irct.ir/trial/17526 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects in each group of severe or moderate deficiencies were randomly divided into 4 subgroups using permuted block randomization by a biostatistician to achieve balance across treatment groups. The number of subjects per block was 8. Sealed opaque envelopes were assigned to each subject by a research assistant not associated in the trial, Blinding description: The dedicated study midwife treating the females, who did not participate in any subsequent phases of the study, was the only person who knew the group each patient belonged to (single blinded). Masking to treatment allocation was not possible and only those health care workers who determined pregnancy outcomes were blinded to treatment allocation. 1 Vitamin D deficiency. Intervention 1: Control group C: Subjectes are observed only about outcomes with no intervention.-9. Intervention 2: 6- Internention group B1,2 : Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 6 weeks and then termination of intervention(100). Intervention 3: 7-Intervention group B2,1 :Subjects(200) are treated with Intramascular administration of 300000 IU vitD3 for 1 dose and after 6 weeks they recive 50000IU oral vitaminD3 monthly until delivey. Intervention 4: 8-Intervention group B2,2 :Subjects(200) are treated with Intramascular administration of 300000 IU vitD3 for 1 dose and then termination of intervention(100). Intervention 5: 2-Intervention group A1,2:Subjects are treatded with 50000IU oral vitaminD3 weekly for a total duration of 12 weeks and then termination of intervention(100). Intervention 6: 3-Intervention groupA2,1: Subjects are treated with Intramascular administration of 300000 IU vitaninD3 each 6 week for 2 doses and then they recive 50000IU oral vitaminD3 monthly until delivery(100). Intervention 7: 5- Internention group B1,1 : Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 6 weeks and they recive 50000IU oral vitaminD3 monthly until delivery(100). Intervention 8: 4-Intervention groupA2,2: Subjects are treated with Intramascular administration of 300000 IU vitaminD3 each 6 week for 2 doses and then termination of intrevention(100). Intervention 9: 1-Intervention group A1 ,1: Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 12 weeks and they recive 50000IU oral vitD3 monthly until delivery(100). Undecided - It is not yet known if there will be a plan to make this available
public Maryam Rostami
No 7,Phase 1 of Farhangiam,
Masjed Soleyman Iran (Islamic Republic of) 6491796581 +98 68 1222 5471 m6326726@gmail.com School of Nursing and Midwifery Shahid Beheshti Medicl University scientific Dr Farhad Hossein panah
No 24, Parvaneh Street, Yaman Street, Velenjak, Tehran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2500 farhad.hosseinpanah@gmail.com Endocrine Reseatch Center Shahid beheshti University of Medical Sciences Iran (Islamic Republic of) Pregnant women Current residence in Masjed Soleyman Gestational age under 14 weeks Maternal age18-40 years Singleton pregnancy 18 years 40 years Female Diabetes Chronic hypertension Thyroid diseases Renal dysfunction Cardiovascular diseases Current use of anticonvulsant drugs Phenytoin Carbamazepine Steroidal drugs Anti cholesterol Digoxin Use of any dietary supplement containing more than 400 IU/day of vitamin D E55 Avitaminosis D Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group C: Subjectes are observed only about outcomes with no intervention.-9 6- Internention group B1,2 : Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 6 weeks and then termination of intervention(100) 7-Intervention group B2,1 :Subjects(200) are treated with Intramascular administration of 300000 IU vitD3 for 1 dose and after 6 weeks they recive 50000IU oral vitaminD3 monthly until delivey. 8-Intervention group B2,2 :Subjects(200) are treated with Intramascular administration of 300000 IU vitD3 for 1 dose and then termination of intervention(100). 2-Intervention group A1,2:Subjects are treatded with 50000IU oral vitaminD3 weekly for a total duration of 12 weeks and then termination of intervention(100). 3-Intervention groupA2,1: Subjects are treated with Intramascular administration of 300000 IU vitaninD3 each 6 week for 2 doses and then they recive 50000IU oral vitaminD3 monthly until delivery(100). 5- Internention group B1,1 : Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 6 weeks and they recive 50000IU oral vitaminD3 monthly until delivery(100). 4-Intervention groupA2,2: Subjects are treated with Intramascular administration of 300000 IU vitaminD3 each 6 week for 2 doses and then termination of intrevention(100). 1-Intervention group A1 ,1: Subjects are treated with 50000IU oral vitD3 weekly for a total duration of 12 weeks and they recive 50000IU oral vitD3 monthly until delivery(100). Abortion. Timepoint: In intervention. Method of measurement: Yes/ No. Preterm Lobour. Timepoint: In intervention. Method of measurement: Yes/ No. Gestational Diabetes. Timepoint: In intervention. Method of measurement: Yes/ No. Preeclampsia. Timepoint: In intervention. Method of measurement: Yes/ No. Serum 25(OH)D concentration in mother. Timepoint: In intervention. Method of measurement: Ng/ml. Birth weigth. Timepoint: after intervention. Method of measurement: gr. Head circumference. Timepoint: After intervention. Method of measurement: Cm. Cord blood 25(OH)D level. Timepoint: After intervention. Method of measurement: Ng/ml. Birth Lenght. Timepoint: After intervention. Method of measurement: Cm. Cord blood Calcium. Timepoint: After intervention. Method of measurement: Ng/ml. Apgar Score 1 minute and 5 minute. Timepoint: After intervention. Method of measurement: Standard Apgar Score. Fall of umbilical cord time. Timepoint: After intervention. Method of measurement: Day. Neonatal Ecterus. Timepoint: After intervention. Method of measurement: Mg/dl. Medical Sciences for Research of Shahid Beheshti Medical university Approved 2013-12-16 Ethical Committee of Shahid Beheshti Medical University No 24, Parvaneh Street, Yaman Street, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)