Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

Study Overview
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Brief Summary
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The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.

Detailed Description
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Vitamin D (vit D) deficiency is a risk factor of osteopenia of prematurity, which leads to rickets or decreased bone mass mineral density. Recently multiple studies have been published on vit D adjust biological functions. Dosage, safety and effectiveness of vitD supplementation in preterm infants still remains a controversial topic. We hypothesize that monitored supplementation of vit D is more effective and safer than standard therapy 500IU in preterm infants. The study will be carried out in 138 preterm infants, born at 24-32 week of gestational age (GA) at the Princess Anne's Hospital in Warsaw, Poland. We will determine if monitored supplementation of vit D decreases the incidence of vit D deficiency and/or overdosing at 40 week (GA). For secondary objective we shall assess if monitored therapy reduces the incidence of vit D deficiency and/or overdosing at 35, 52 week (GA), prevalence of osteopenia, low bone mass, nephrocalcinosis and nephrolithiasis.

Official Title
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Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial

Conditions
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Vitamin D Deficiency, Osteopenia, Nephrolithiasis, Drug Overdose

Intervention / Treatment
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* Dietary Supplement: monitored vit D supplementation
* Dietary Supplement: standard vit D supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound) In born or admitted to the unit within 48hours from birth. Randomization within 7 days from birth. Parental consent. Mothers willing to return for follow up visits. Exclusion Criteria: Preterm delivery >=33 weeks of gestation or term delivery (estimated by ultrasound). Major congenital abnormalities. Participation in another trial. Severe illness at birth deemed incompatible with survival. Congenital HIV infection. Total parenteral nutrition > 14 days. Cholestasis

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: monitored group<br>The monitored group will received monitored vit D supplementation | Dietary Supplement: monitored vit D supplementation<br>* The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born <30 GA, at 8 week of age for infants born <26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol.<br>|
| Active Comparator: standard group<br>The standard group will receive standard vit D supplementation | Dietary Supplement: standard vit D supplementation<br>* The vitamin D supplementation dose is 500IU from 7th day of age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with D- deficiency or access | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) | at 40 (+/-2 weeks) PMA (postmenstrual age) | 
| Number of Participants with D- deficiency or access | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) | at 4 weeks of age | 
| Number of Participants with D- deficiency or access | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) | At 35 (+/-2 weeks) PMA (postmenstrual age) | 
| Number of Participants with D- deficiency or access | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) | At 52 (+/-2 weeks) PMA (postmenstrual age) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with biochemical markers of osteopenia | ALP>500IU and serum phosphate level <1,8mmol/l or ALP>900IU | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) | 
| average of bone mass | measurement of speed of sound [SOS] in meters per second in the axial transmission mode with a small ultrasound probe along the mid tibia by Sunlight Omnisence 7000 Premier using CRB Probe | at 35, 40 (+/-2 weeks) PMA | 
| Number of Participants with hypercalcemia | serum calcium level above 2,75mmol/l | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) | 
| Number of Participants with hypercalcuria | urine calcium:creatinine ratio >3,8mmol/mmol for 0-4 week of age; >3,5mmol/mmol for 5-8 week of age; >2,8mmol/mmol for 9-12 week of age; >2,5mmol/mmol for 13-18 week of age; >2,2mmol/mmol for >19 week of age | at 35, 40, 52 (+/-2 weeks) PMA | 
| Number of Participants with nephrocalcinosis | nephrocalcinosis detected in ultrasonography examination of kidneys | at 35, 52 (+/-2 weeks) PMA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, supplementation, hydroxyvitamin D, pretrem infants, osteopenia