Comparison of Two Different Doses of Vitamin D in Preterm Infants

Not Applicable

• Conditions: Osteopenia of Prematurity

• Registration Number: NCT03889717
• Lead Sponsor: Cairo University

Brief Summary

randomized clinical trial comparing two different doses of vitamin d supplementation in preterm infants

Detailed Description

after randomization each group of preterm neonates (28-32) weeks consisting of 40 neonates

within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate

then babies started to take oral vitamin d in different doses (400 IU /day in the 1st group and 1000 iu per day in the 2nd group) after they reach 100 cc per kg per day enteral feeding

after they complete 40th week gestational age the investigators repeat the labs again ( serum ca, phosphorus,alp and vitamin D and compare the rate of rise in vitamin D and calcium

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Status Verified: 2019-04
• Study Start: 2019-04-16
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Preterm infants delivered at a gestational age ≤ 32 weeks
• Birth weight ≤1500 kg

Exclusion Criteria

• Neonates with major congenital anomalies,
• maternal condition or medications likely to influence vitamin D or calcium metabolism
• neonates not receiving 100 ml/ kg / day of enteral feeds by 14 days of life

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups.	1 month	measurement of the level after supplementation

Trial Locations

Locations (1)

Kasr alainy; 🇪🇬 Cairo, Egypt