Comparison of Two Different Doses of Vitamin D in Preterm Infants

Study Overview
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Brief Summary
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randomized clinical trial comparing two different doses of vitamin d supplementation in preterm infants

Detailed Description
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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consisting of 40 neonates within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate then babies started to take oral vitamin d in different doses (400 IU /day in the 1st group and 1000 iu per day in the 2nd group) after they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

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

Conditions
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Osteopenia of Prematurity

Intervention / Treatment
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* Dietary Supplement: vitamin D


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: after randomization ,two different groups of premature neonates are enrolled in the study baseline calcium,phosphorus and alp and vitamin D withdrawn at the 1st 48 hrs, then neonates started to administer vitamin D drops after they reached 100 cc per kg per day until they complete 40th week gestational age .follow up labs will be done at this age to determine which dose is better in vitamin d deficiency prevention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 iu<br>neonates who will receive vitamin d dose at 400 iu per day | Dietary Supplement: vitamin D<br>* 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<br>|
| Active Comparator: 1000 iu<br>neonates who will receive vitamin d dose 1000 iu per day | Dietary Supplement: vitamin D<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |