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

February 10, 2021 updated by: Alicja Kołodziejczyk, Princess Anna Mazowiecka Hospital, Warsaw, Poland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 00-315
        • Princess Anna Mazowiecka Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: monitored group
The monitored group will received monitored vit D supplementation
Dietary supplement: monitored vit D supplementation
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.
Active Comparator: standard group
The standard group will receive standard vit D supplementation
Dietary supplement: standard vit D supplementation
The vitamin D supplementation dose is 500IU from 7th day of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with D- deficiency or access
Time Frame: at 40 (+/-2 weeks) PMA (postmenstrual age)
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
Time Frame: at 4 weeks of age
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
Time Frame: At 35 (+/-2 weeks) PMA (postmenstrual age)
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
Time Frame: At 52 (+/-2 weeks) PMA (postmenstrual age)
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
Time Frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
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
Time Frame: at 35, 40 (+/-2 weeks) PMA
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
Time Frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
serum calcium level above 2,75mmol/l
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Number of Participants with hypercalcuria
Time Frame: at 35, 40, 52 (+/-2 weeks) PMA
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
Time Frame: at 35, 52 (+/-2 weeks) PMA
nephrocalcinosis detected in ultrasonography examination of kidneys
at 35, 52 (+/-2 weeks) PMA

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with vitamin D- acceptable range
Time Frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 80ng/ml (200nmol/l )
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Number of Participants with vitamin D- optimal range
Time Frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 50ng/ml (125nmol/l )
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Avarage of vitamin D level
Time Frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level
at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Collaborators

Medical University of Warsaw

Investigators

  • Study Chair: Maria K Borszewska-Kornacka, Professor, Princess Anna Mazowiecka Hospital
  • Study Director: Renata Bokiniec, M.D., Princess Anna Mazowiecka Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitD-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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