Comparison of Two Different Doses of Vitamin D in Preterm Infants

Cairo University (CU)

Status: Unknown

Conditions: Osteopenia of Prematurity

Treatments: Dietary Supplement: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT03889717

DPTL

Details and patient eligibility

About

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

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within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate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

Enrollment: 80 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

400 iu

Experimental group

Description:

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

Treatment:

Dietary Supplement: vitamin D

1000 iu

Active Comparator group

Description:

neonates who will receive vitamin d dose 1000 iu per day

Treatment:

Dietary Supplement: vitamin D