Evidence map›Paper›PMID 28893306›Full record

Trial reportTrials2017

MOnitored supplementation of VItamin D in preterm infants (MOSVID trial): study protocol for a randomised controlled trial.

Alicja Kołodziejczyk, Maria K Borszewska-Kornacka, Joanna Seliga-Siwecka

Registry-linked trialOpen access · goldAbstract readPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03087149 (Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03087149 nacompletednot on this map

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

TypeinterventionalSponsorPrincess Anna Mazowiecka Hospital, Warsaw, PolandRan2017 to 2020Enrolled109ConditionsVitamin D Deficiency, Osteopenia, Nephrolithiasis, Drug OverdoseArmsmonitored vit D supplementation, standard vit D supplementation
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Expert consensus on clinical management of metabolic bone disease of prematurity (2021).Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2021
    Article
  7. Article
  8. Bronchopulmonary Dysplasia: An Update on Experimental Therapeutics.European Medical Journal (Chelmsford, England) · 2019
    Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Alicja KołodziejczykNeonatal and Intensive Care Department, Medical University of Warsaw, Karowa 2 Street, 00-315, Warsaw, Poland.
Maria K Borszewska-KornackaNeonatal and Intensive Care Department, Medical University of Warsaw, Karowa 2 Street, 00-315, Warsaw, Poland.
Joanna Seliga-SiweckaNeonatal and Intensive Care Department, Medical University of Warsaw, Karowa 2 Street, 00-315, Warsaw, Poland. joanna.seliga@wum.edu.pl.ORCID 0000-0002-4628-0541
Medical University of Warsaw · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe pivotal role of vitamin D (vit D) in skeletal health is well known. Neonatal vit D storage at birth is dependent on maternal levels, and newborns receive 50-70% of their mother's 25-hydroxyvitamin D [25(OH)D]. Deficiency of vit D can lead to prematurity bone disease, with an incidence of up to 55% in infants weighing < 1000 g. The aim of this study is to assess the effectiveness of monitored supplementation of vit D in a population of preterm infants. METHODS/

designPreterm infants born at 24-32 weeks of gestation will be recruited within the first 7 days of life. Depending on the type of feeding, and after reaching partial enteral feeding or at 7 days of life, vit D supplementation will consist of 500 IU and an additional 150-300 IU/kg included in human milk fortifiers (if fed exclusively with breast milk) or 190 IU/kg in milk formulas. Subjects will be randomised to either monitored (with an option of dose modification based on 25(OH)D levels as per protocol) or standard therapy up to 52 weeks of post-conceptional age (PCA). The primary outcome measure will be the number of neonates with deficiency or excess levels of 25(OH)D at 40  ±2 weeks of PCA. Additional 25(OH)D levels will be measured at birth, at 4 and 8 weeks of age, and/or at 35 and 52  ±2 weeks of PCA. Secondary objectives will include the incidence of osteopenia, nephrocalcinosis and nephrolithiasis. Serum parameters of calcium phosphorus metabolism will also be measured. DISCUSSION: Despite multiple years of research and numerous publications, there is still a lack of consensus in regard to how much vit D infants should receive and how long they should receive it. Because 80% of calcium and phosphorus placental transfer occurs between 24 and 40 weeks of gestation, preterm infants are especially prone to adverse effects of vit D insufficiency. However, both inadequate and excessive amounts of vit D may be unsafe and lead to serious health issues. The results of our study may shed new light on these concerns and contribute to optimising vit D supplementation.

trial registrationClinicalTrials.gov, NCT03087149 . Registered on 15 March 2017.

Indexed as

Dietary SupplementsInfant, PrematurePremature BirthBiomarkersBone Diseases, MetabolicCholecalciferolClinical ProtocolsGestational AgeHumansIncidenceInfantInfant, NewbornNephrocalcinosisNephrolithiasisPolandResearch Design25-hydroxyvitamin DBiomarkersCholecalciferolVitamin DOsteopeniaPrematurityVitamin D

Identifiers

PMID28893306
PMCPMC5594536
OpenAlexW2756432854

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.