Comparison of Two Different Doses of Vitamin D in Preterm Infants
Primary Purpose
Osteopenia of Prematurity
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Osteopenia of Prematurity
Eligibility Criteria
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
Sites / Locations
- Kasr alainyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
400 iu
1000 iu
Arm Description
neonates who will receive vitamin d dose at 400 iu per day
neonates who will receive vitamin d dose 1000 iu per day
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03889717
Brief Title
Comparison of Two Different Doses of Vitamin D in Preterm Infants
Official Title
A Randomized Controlled Trial Comparing Two Regimens of Vitamin D Supplementation in Preterm Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
June 15, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia of Prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
400 iu
Arm Type
Experimental
Arm Description
neonates who will receive vitamin d dose at 400 iu per day
Arm Title
1000 iu
Arm Type
Active Comparator
Arm Description
neonates who will receive vitamin d dose 1000 iu per day
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
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
Primary Outcome Measure Information:
Title
Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups.
Description
measurement of the level after supplementation
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Basta, master
Phone
00201002866168
Email
deena-gamal@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
douaa Ibrahim, master
Phone
00201006155597
Email
douaa.galal@hotmail.com
Facility Information:
Facility Name
Kasr alainy
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Two Different Doses of Vitamin D in Preterm Infants
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