Comparison of Two Different Doses of Vitamin D in Preterm Infants

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03889717

Enrollment

Registered

2019-03-26

Start date

2019-04-16

Completion date

2019-06-30

Last updated

2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia of Prematurity

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consisting of 40 neonates within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate then babies started to take oral vitamin d in different doses (400 IU /day in the 1st group and 1000 iu per day in the 2nd group) after they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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention 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,two different groups of premature neonates are enrolled in the study baseline calcium,phosphorus and alp and vitamin D withdrawn at the 1st 48 hrs, then neonates started to administer vitamin D drops after they reached 100 cc per kg per day until they complete 40th week gestational age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

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactDina Basta, master

deena-gamal@hotmail.com00201002866168

Backup Contactdouaa Ibrahim, master

douaa.galal@hotmail.com00201006155597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026