Comparison of Two Different Doses of Vitamin D in Preterm Infants

April 25, 2019 updated by: Dina Jamal Abd elmoez abd elmegeed Basta, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate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

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 002
        • Recruiting
        • Kasr Alainy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 400 iu
neonates who will receive vitamin d dose at 400 iu per day
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
Active Comparator: 1000 iu
neonates who will receive vitamin d dose 1000 iu per day
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

What is the study measuring?

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.
Time Frame: 1 month
measurement of the level after supplementation
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Anticipated)

June 15, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

March 22, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPTL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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