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Status unknownNCT03889717Updated Apr 26, 2019

Comparison of Two Different Doses of Vitamin D in Preterm Infants

An interventional study of vitamin D in Osteopenia of Prematurity, sponsored by Cairo University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2019-04-26.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
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Study summary

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

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within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate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

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Conditions studied

  • Osteopenia of Prematurity
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In context

Bone Diseases, Metabolic

470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    400 iu

    neonates who will receive vitamin d dose at 400 iu per day

    Dietary Supplement: vitamin D

  • Active comparator
    1000 iu

    neonates who will receive vitamin d dose 1000 iu per day

    Dietary Supplement: vitamin D

Interventions

  • Dietary supplementvitamin 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

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Study locations

1 of 1 sites recruiting
  • Kasr alainy
    Cairo, 002, Egypt
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03889717
Lead sponsor
Cairo University
Responsible party
Dina Jamal Abd elmoez abd elmegeed Basta (Principal investigator, Cairo University) — Principal investigator
First posted
Mar 26, 2019
Start date
Apr 16, 2019
Primary completion
Jun 15, 2019 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
Apr 26, 2019

Study contacts

Dina Basta, master
Contact
deena-gamal@hotmail.com
00201002866168
douaa Ibrahim, master
Contact
douaa.galal@hotmail.com
00201006155597

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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