Comparison of Two Different Doses of Vitamin D in Preterm Infants

NCT03889717 | Unknown

• 1 other identifier: DPTL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteopenia of Prematurity

Outcome Measures

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

  1 month

Study Arms (2)

400 iu

EXPERIMENTAL

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

Dietary Supplement: vitamin D

1000 iu

ACTIVE COMPARATOR

neonates who will receive vitamin d dose 1000 iu per day

Dietary Supplement: vitamin D

Interventions

vitamin D DIETARY_SUPPLEMENT

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

1000 iu; 400 iu

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr alainy

Cairo, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Dina Basta, master

CONTACT

00201002866168; deena-gamal@hotmail.com

douaa Ibrahim, master

CONTACT

00201006155597; douaa.galal@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 26, 2019
• Study Start: April 16, 2019
• Primary Completion: June 15, 2019
• Study Completion: June 30, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

EG (1)