Comparison of Two Different Doses of Vitamin D in Preterm Infants

Osteopenia of Prematurity Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Two Regimens of Vitamin D Supplementation in Preterm Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03889717
• Other study ID #: DPTL
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2019
• Source: Cairo University
• Contact: Dina Basta, master
• Phone: 00201002866168
• Email: deena-gamal[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia of Prematurity

Intervention

Dietary Supplement:
• vitamin D
vitamin d drops will be given daily to the 2 groups of neonates ( 1st group will be given 400 iu /day and 2nd group will be given 1000 iu per day ) when they reach 100 cc per kg enteral feeding .. until they reach 40 weeks gestational age

Locations

Country	Name	City	State
Egypt	Kasr alainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups.	measurement of the level after supplementation	1 month