Comparison of the effect of vitamin D with doses of 400 and 1000 units per day on biochemical and radiological indicators of metabolic bone disease in premature infants born to mothers with insufficient levels of vitamin D, a double-blind randomized clinical trial

Comparison of the effect of vitamin D with doses of 400 and 1000 units per day on biochemical and radiological indicators of metabolic bone disease in premature infants born to mothers with insufficient levels of vitamin D

In this randomized, double-blind phase 3 clinical trial, 90 eligible premature infants will be enrolled in two parallel intervention groups by block randomization (using "www.sealedenvelope.com") and will receive a daily dose of 400 and 1000 units of vitamin D, respectively.

This study will be performed in the neonatal units and neonatal intensive care units of Bu-Ali Sina and Imam Khomeini Hospitals in Sari. The containers of vitamin D (that will all be prepared from the same factory) will be labeled with unique numbers in such a way that the concentration of the product is not known. All infants receive the same daily volume (1 mL) and the outcome assessors will not be informed of the vitamin D dose consumed by each infant. Serum calcium, phosphate, alkaline phosphatase, and 25-hydroxy D3 are measured at baseline, 6 and 12 weeks. Also, at 6 and 12 weeks, an x-ray of the left wrist and physical examination will be done by physicians who are blind about interventions and lab tests.

Inclusion criteria: Premature infants with an age of less than 14 days; a gestational age of less than 34 weeks; a birth weight of less than 1800 grams; born to mothers with insufficient levels of vitamin D. Exclusion criteria: Infant suffering from chromosomal disorder syndromes; Other bone metabolic diseases except rickets; Having cholestasis; Kidney dysfunction (increased serum creatinine equal to or more than 50% of normal)

Intervention group 1: Premature infants receiving 400 IU/ day of vitamin D; Intervention group 2: Premature infants receiving 1000 IU/ day of vitamin D

Serum calcium, phosphate, alkaline phosphatase, and 25(OH)D3

Infants who meet the conditions for entering the study and informed consent form have completed by their father or mother, by block randomization method (using the www.sealedenvelope.com system) and creating 9 blocks of size 10 and generating a three-digit code (combination of letters and numbers) will be allocated in two groups according to the amount of vitamin D supplement received. Each set of ten random codes is entered in a sealed envelope and given to the head nurse of the ward (who is independent from the main researchers). When each eligible patient enters the study, one of the codes is taken out from the envelope and according to that, the drug with the same code is given to the patient and the intervention is assigned to the patient according to the treatment group.

For blinding, the containers of vitamin D (that will all be prepared from the same factory) will be labeled with unique numbers (special for each patient based on the assigned code) in such a way that the dose (400 or 1000) is not known and all infants receive the same daily volume (1 mL). Only the main investigator of the project is aware of the content of the drug with a specific code and it will remain confidential until the end of the study. Therefore, the outcome assessors will not be informed of the vitamin D dose consumed by each infant.

All data is potentially shareable after making individuals unidentified.

Access period starts 6 months after the results are published

Researchers in academic and scientific institutions

For information on the details of the study without doing new statistical analysis

Sending an email to mrrafati@mazums.ac.ir

The email will be checked, if the request is clear and the conditions are met, the information will be sent.