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Monitored vs Standard Supplementation of Vitamin D in Preterm Infants (MOSVID)

Primary Purpose

Vitamin D Deficiency, Osteopenia, Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
monitored vit D supplementation
standard vit D supplementation
Sponsored by
Princess Anna Mazowiecka Hospital, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring vitamin D, supplementation, hydroxyvitamin D, pretrem infants, osteopenia

Eligibility Criteria

1 Day - 7 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Anna Mazowiecka Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

monitored group

standard group

Arm Description

The monitored group will received monitored vit D supplementation

The standard group will receive standard vit D supplementation

Outcomes

Primary Outcome Measures

Number of Participants with D- deficiency or access
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Number of Participants with D- deficiency or access
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Number of Participants with D- deficiency or access
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Number of Participants with D- deficiency or access
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )

Secondary Outcome Measures

Number of Participants with biochemical markers of osteopenia
ALP>500IU and serum phosphate level <1,8mmol/l or ALP>900IU
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
Number of Participants with hypercalcemia
serum calcium level above 2,75mmol/l
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
Number of Participants with nephrocalcinosis
nephrocalcinosis detected in ultrasonography examination of kidneys

Full Information

First Posted
March 15, 2017
Last Updated
February 10, 2021
Sponsor
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Collaborators
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT03087149
Brief Title
Monitored vs Standard Supplementation of Vitamin D in Preterm Infants
Acronym
MOSVID
Official Title
Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Collaborators
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Osteopenia, Nephrolithiasis, Drug Overdose
Keywords
vitamin D, supplementation, hydroxyvitamin D, pretrem infants, osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
monitored group
Arm Type
Experimental
Arm Description
The monitored group will received monitored vit D supplementation
Arm Title
standard group
Arm Type
Active Comparator
Arm Description
The standard group will receive standard vit D supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
monitored vit D supplementation
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
standard vit D supplementation
Intervention Description
The vitamin D supplementation dose is 500IU from 7th day of age.
Primary Outcome Measure Information:
Title
Number of Participants with D- deficiency or access
Description
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Time Frame
at 40 (+/-2 weeks) PMA (postmenstrual age)
Title
Number of Participants with D- deficiency or access
Description
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Time Frame
at 4 weeks of age
Title
Number of Participants with D- deficiency or access
Description
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Time Frame
At 35 (+/-2 weeks) PMA (postmenstrual age)
Title
Number of Participants with D- deficiency or access
Description
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Time Frame
At 52 (+/-2 weeks) PMA (postmenstrual age)
Secondary Outcome Measure Information:
Title
Number of Participants with biochemical markers of osteopenia
Description
ALP>500IU and serum phosphate level <1,8mmol/l or ALP>900IU
Time Frame
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Title
average of bone mass
Description
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
Time Frame
at 35, 40 (+/-2 weeks) PMA
Title
Number of Participants with hypercalcemia
Description
serum calcium level above 2,75mmol/l
Time Frame
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Title
Number of Participants with hypercalcuria
Description
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
Time Frame
at 35, 40, 52 (+/-2 weeks) PMA
Title
Number of Participants with nephrocalcinosis
Description
nephrocalcinosis detected in ultrasonography examination of kidneys
Time Frame
at 35, 52 (+/-2 weeks) PMA
Other Pre-specified Outcome Measures:
Title
Number of Participants with vitamin D- acceptable range
Description
25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 80ng/ml (200nmol/l )
Time Frame
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Title
Number of Participants with vitamin D- optimal range
Description
25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 50ng/ml (125nmol/l )
Time Frame
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Title
Avarage of vitamin D level
Description
25-hydroxyvitamin D serum level
Time Frame
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria K Borszewska-Kornacka, Professor
Organizational Affiliation
Princess Anna Mazowiecka Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Renata Bokiniec, M.D.
Organizational Affiliation
Princess Anna Mazowiecka Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Princess Anna Mazowiecka Hospital
City
Warsaw
ZIP/Postal Code
00-315
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
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Links:
URL
http://www.ilexmedical.com/files/download/1382861508z08Qo.pdf
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Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

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