Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity

Alexandria University

Status and phase: Completed; Phase 2

Conditions: Osteopenia of Prematurity

Treatments: Drug: High Dose Vitamin D; Drug: Low Dose Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT04768439

00007555-00015712

Details and patient eligibility

About

In this study the effects of low and high doses of prophylactic vitamin D on biochemical and radiological manifestations of osetopenia of prematurity will be tested.

Full description

The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and delivered at Alexandria University Maternity Hospital (AUMH).

Enrollment: 80 patients

Sex: All

Ages: 1 day to 2 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborns with gestational age of ≤ 32 weeks and birth weight ≤ 1500 g.

Exclusion criteria

• Newborns whose mothers were taking specific medications interacting with vitamin D metabolism (e.g., anticonvulsants, diuretics)
• Being NPO (nothing per oral) for more than 2 wks
• Gestational age more than 32 weeks
• Birth weight more than 1500 grams

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

200 IU/d vitamin D

Experimental group

Description:

Patients will receive low-dose vitamin D (200 IU/d)

Treatment:

Drug: Low Dose Vitamin D

1600 IU/d vitamin D

Experimental group

Description:

Patients will receive high-dose vitamin D (1600 IU/d)

Treatment:

Drug: High Dose Vitamin D