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IRCT20171030037093N4 IRCT 2019-03-03 Shahre-kord University of Medical Sciences Effect of vitamin D supplementat on the level of serum vitamin D in preterm neonates Comparing the effect of different doses of vitamin D supplement on the level of serum 25(OH) vitamin D and bone metabolism related factors in preterm neonates 2018-07-25 anticipated 100 Complete https://irct.ir/trial/37624 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Cases are randomized using random allocation through the software. In this way, after the selection of 100 preterm infants that have the inclusin criterias, neonates are randomly assigned to one of the two intervention groups by statistical software. 2-3 Vitamin D deficiency in premature infants. Intervention 1: Intervention group: reciving 300 units of vitamin D through FMS supplement plus 100 units of A + D drop ( 400 unints per cc , Behsa) plus distilled water. Intervention 2: Intervention group: reciving 300 units of vitamin D through FMS supplement plus 100 units of A + D drop ( 400 unints per cc , Behsa) plus 400 units of vitamin D drop (1000 units per cc vitabiotics). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I will decide untill finishing the study
public Roya Choopani
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3227 4004 choopani.r@skums.ac.ir Shahre-kord University of Medical Sciences scientific Roya Choopani
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3227 4004 choopani.r@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Gestational age between 28 and 34 weeks The absence of major disorders and malformations The absence of systemic diseases, such as asphyxia and cholestasis 1 day 30 days Both Supportive nutrition for more than 2 weeks Use of anticonvulsant and anti HIV drugs by the infant's mother Use of injectable vitamin D during the study Formula feeding Nephrocalcinosis in the infant E55 Vitamin D deficiency Treatment - Drugs Treatment - Drugs Intervention group: reciving 300 units of vitamin D through FMS supplement plus 100 units of A + D drop ( 400 unints per cc , Behsa) plus distilled water Intervention group: reciving 300 units of vitamin D through FMS supplement plus 100 units of A + D drop ( 400 unints per cc , Behsa) plus 400 units of vitamin D drop (1000 units per cc vitabiotics) Serum level of 25 hydroxy vitamin D. Timepoint: Beginning of study, Modified age 40 weeks after LMP. Method of measurement: Blood sample. Serum level of calcium. Timepoint: Beginning of study, Modified age 40 weeks after LMP. Method of measurement: Blood sample. Serum level of Phosphorus. Timepoint: Beginning of study, Modified age 40 weeks after LMP. Method of measurement: Blood sample. Serum level of Alkaline phosphatase. Timepoint: Beginning of study, Modified age 40 weeks after LMP. Method of measurement: Blood sample. . Timepoint: . Method of measurement: . Shahre-kord University of Medical Sciences Approved 2018-06-24 Ethics Committee of Shahrekord University of Medical Sciences Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)