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NCT Number: NCT04768439

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

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.

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Key information

Conditions

Osteopenia of Prematurity Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

1 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 21131, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Dose Vitamin D

Drug

Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.

Other names: 1,25-Dihydroxycholecalciferol

High Dose Vitamin D

Drug

Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.

Other names: 1,25-Dihydroxycholecalciferol

Primary outcomes

  1. Calcium level and activity

    Time frame: six weeks

    Serum calcium level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 8.5 to 10.5 mg/dl

  2. Phosphorus level and activity

    Time frame: six weeks

    Serum phosphorus level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 3.4 to 4.5 mg/dl

  3. Alkaline phosphatase level and activity

    Time frame: six weeks

    Serum alkaline phosphate level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 50-100 U/L.

  4. 25-Hydroxy Vitamin D

    Time frame: six weeks

    Serum 25-Hydroxy Vitamin D level will be measured and analyzed using Electrochemilumiescence binding assay on cobas e immunoassay analyzer. The reference range of the total 25(OH)D level is 25-80 ng/mL.

  5. Bone fracture

    Time frame: six weeks

    This will be evaluated using an x-ray of left wrist

  6. Intracortical resorption

    Time frame: six weeks

    This will be evaluated using an x-ray of left wrist

  7. Losing the sharp bone border (fraying)

    Time frame: six weeks

    This will be evaluated using an x-ray of left wrist

  8. Cupping of metaphyseal edge of bone

    Time frame: six weeks

    This will be evaluated using an x-ray of left wrist

  9. Widening of the distal end of the metaphysis of bone

    Time frame: six weeks

    This will be evaluated using an x-ray of left wrist

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2021
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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