AzTrials
AzTrials

Infant, Premature, DiseasesPhase 3Ca-PNCT03691896

Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)

A Phase 3 study testing Cholecalciferol 400, Cholecalciferol 800 and Cholecalciferol 1200 in people with Infant, Premature, Diseases, run by Centre of Postgraduate Medical Education at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

It has not yet been established the optimal dose of vit. D for preterm infants in Poland. It is not known what dose of vit. D will provide the correct concentration of vit. D and the optimal development of the skeleton of the premature. Read more about this study

Who is it for?
Ages 24 to 32 weeks
Conditions the study is for
Infant, Premature, Diseases
What is being tested?
Cholecalciferol 400, Cholecalciferol 800 and Cholecalciferol 1200
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 sitePoland
Study dates
Jan 2016to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • gestational age ≤32 weeks at birth
  • hospitalization in the department no later than at the age of 7 days (for infants born outside the center)
  • No birth defects or diseases permanently affecting the ability to accept enteral feeding
  • Anticipated possibility of continuous monitoring of the course of treatment in hospital until discharge
  • Consent of Parents / legal guardians for the participation in the study.

Who cannot join

  • gestational age> 32 weeks at birth
  • the beginning of hospitalization in the department later than the age of 7 days (for infants born outside the center)
  • presence of congenital defects or diseases permanently affecting the ability to accept enteral feeding (e.g.oesophageal atresia, anal atresia, congenital umbilical hernia, gastroschisis, syndromes genetically determined)
  • significant interruption (> 1 week) of the hospitalization in the center
  • lack of consent of the Parents / legal guardians to participation in the study

Trial locations and contacts

1 site in 1 country.

Magdalena Zarlenga, MD contact

+48224851171

magda.cmkp@gmail.com

Maria Wilińska, DSc contact

+48225841170

Poland1 site, 1 recruiting

  • SPSK im. prof. W.Orłowskiego CMKP Neonatology Departament

    Warsaw, Masovian Voivodeship, 00-416

    Recruiting

Other trials in Poland

About this study

Official title: The Impact of the Dose of Vitamin D (vitD) on the Metabolism of ca, p and Concentrations of 25OHD, Bone Status and Development of Premature Infants up to 2 Years of Age. Prospective, Randomized, Clinical Study

It has not yet been established the optimal dose of vit. D for preterm infants in Poland. It is not known what dose of vit. D will provide the correct concentration of vit. D and the optimal development of the skeleton of the premature.

The study will try to determine the optimal supplementation of vitamin D and the supply of Ca and P for normal growth and development of a child born prematurely.

In addition, the investigators will evaluate any risk factors for deficiency and excess of vitamin D and the consequences of its deficiency and overdose. Simultaneously the study would make possible the determination of an optimal schedule for controlling the Ca-P levels in the group of the youngest infants born prematurely. In addition, the study will assess the relationship between maternal and newborn vitamin D resources right after birth, and the incidence of vitamin D deficiency in infants born prematurely. Preterm infants will be randomized in 3 groups assigned to different doses of vit. D. The study will investigate the metabolism of calcium, phosphorus, the health of bones and development of the premature babies till the age of 2.

Read the detailed description

The participants of the study will be prematures, born ≤32 GA, hospitalized in the Department of Neonatology, in the neonatal intensive care unit. Hospitalized patients who meet the inclusion criteria will be randomized in 3 groups assigned to different doses of vit. D (400, 800 or 1200 units(UNT) of vitamin D).

At defined age points of postnatal life, parameters of calcium and phosphorus metabolism and vitamin D level will be tested, along with the health of bones, health status and development.

Being tested
Cholecalciferol 400, Cholecalciferol 800, Cholecalciferol 1200
Keywords
premature, osteopenia, Vit. D, LBW (low birth weight), 25OHD
Medical subject headings
Infant, Premature, Diseases, Premature Birth, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cholecalciferol 400Dietary supplement

    Also called vit D

    dose 400 UNT/day for 12 months

  • Cholecalciferol 800Dietary supplement

    Also called vit D

    dose 800 UNT/day for 12 months

  • Cholecalciferol 1200Drug

    Also called vit D

    dose 1200 UNT/day for 12 months

Study groups in NCT03691896
Study groupRoleWhat they receive
Lower doseExperimentalcholecalciferol 400UNT, oral solution
Receives: Dietary Supplement: Cholecalciferol 400
Middle doseActive comparatorcholecalciferol 800UNT, oral solution
Receives: Dietary Supplement: Cholecalciferol 800
Higher doseExperimentalcholecalciferol 1200UNT, oral solution,
Receives: Drug: Cholecalciferol 1200

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum 25OHD levels in cord blood in Polish preterm infants

    assessment of 25OH D levels in children deficiency: <10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml

    Measured: day of labour

Secondary outcomes (9)

  1. Impact of supplementation of Vit. D during pregnancy on 25OHD serum level in Polish mothers

    assessment of 25OH D levels in mothers deficiency: <10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml

    Measured: day of labour

  2. Impact of dosage of Vit D3 (400/800/1200 UNT per day) on serum 25OH D levels in preterm children

    assessment of serum 25OH D levels in children deficiency: <10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml; high level > 60ng/ml, toxic level > 100ng/ml

    Measured: 4,8,12 weeks of life,1 and 2 years of age

  3. Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on Ca serum levels

    assessment of Ca serum levels in children

    Measured: 4,8,12 weeks of life,1 and 2 years of age

  4. Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on P serum levels

    assessment of P serum levels in children

    Measured: 4,8,12 weeks of life,1 and 2 years of age

  5. Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary Ca excretion

    assessment of urinary calcium/creatinine index

    Measured: 4,8,12 weeks of life,1 and 2 years of age

  6. Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary P excretion

    assessment of urinary P/creatinine index (mg/mg)

    Measured: 4,8,12 weeks of life,1 and 2 years of age

  7. impact of total annual Vit D3 dose and bone calcification in children

    assessment of bone status :Densitometry (DEXA)

    Measured: average of 1 and 2 years of age

  8. correlation of cord blood 25OHD level and GA

    birth <24 GA, 24-28GA, 28-32GA

    Measured: 1st day of life

  9. impact of cord blood 25OHD level on birth weight

    assessment of percentile of birth weight (Fenton 2013) hypotrophy <3p, eutrophy 3-97p, hypertrophy >97p

    Measured: 1st day of life of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study startJan 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03691896
Sponsor's protocol ID
501-1-13-15-16
Acronym
Ca-P
Status last verified
Sep 2018
First submitted
18 Jun 2016
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bodnar LM, Klebanoff MA, Gernand AD, Platt RW, Parks WT, Catov JM, Simhan HN. Maternal vitamin D status and spontaneous preterm birth by placental histology in the US Collaborative Perinatal Project. Am J Epidemiol. 2014 Jan 15;179(2):168-76. doi: 10.1093/aje/kwt237. Epub 2013 Oct 11.

    PubMed 24124195

  • Monangi N, Slaughter JL, Dawodu A, Smith C, Akinbi HT. Vitamin D status of early preterm infants and the effects of vitamin D intake during hospital stay. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F166-8. doi: 10.1136/archdischild-2013-303999. Epub 2013 Jul 13.

    PubMed 23852093

  • Natarajan CK, Sankar MJ, Agarwal R, Pratap OT, Jain V, Gupta N, Gupta AK, Deorari AK, Paul VK, Sreenivas V. Trial of daily vitamin D supplementation in preterm infants. Pediatrics. 2014 Mar;133(3):e628-34. doi: 10.1542/peds.2012-3395. Epub 2014 Feb 10.

    PubMed 24515510

  • van de Lagemaat M, Rotteveel J, Schaafsma A, van Weissenbruch MM, Lafeber HN. Higher vitamin D intake in preterm infants fed an isocaloric, protein- and mineral-enriched postdischarge formula is associated with increased bone accretion. J Nutr. 2013 Sep;143(9):1439-44. doi: 10.3945/jn.113.178111. Epub 2013 Jul 31.

    PubMed 23902955

  • Schanler RJ, Burns PA, Abrams SA, Garza C. Bone mineralization outcomes in human milk-fed preterm infants. Pediatr Res. 1992 Jun;31(6):583-6. doi: 10.1203/00006450-199206000-00009.

    PubMed 1635820

  • Kislal FM, Dilmen U. Effect of different doses of vitamin D on osteocalcin and deoxypyridinoline in preterm infants. Pediatr Int. 2008 Apr;50(2):204-7. doi: 10.1111/j.1442-200X.2008.02553.x.

    PubMed 18353060

  • Christmann V, de Grauw AM, Visser R, Matthijsse RP, van Goudoever JB, van Heijst AF. Early postnatal calcium and phosphorus metabolism in preterm infants. J Pediatr Gastroenterol Nutr. 2014 Apr;58(4):398-403. doi: 10.1097/MPG.0000000000000251.

    PubMed 24253367

  • Backstrom MC, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Koskinen M, Ikonen RS, Maki M. The long-term effect of early mineral, vitamin D, and breast milk intake on bone mineral status in 9- to 11-year-old children born prematurely. J Pediatr Gastroenterol Nutr. 1999 Nov;29(5):575-82. doi: 10.1097/00005176-199911000-00019.

    PubMed 10554126

  • Fewtrell MS, Prentice A, Jones SC, Bishop NJ, Stirling D, Buffenstein R, Lunt M, Cole TJ, Lucas A. Bone mineralization and turnover in preterm infants at 8-12 years of age: the effect of early diet. J Bone Miner Res. 1999 May;14(5):810-20. doi: 10.1359/jbmr.1999.14.5.810.

    PubMed 10320530

  • McCarthy RA, McKenna MJ, Oyefeso O, Uduma O, Murray BF, Brady JJ, Kilbane MT, Murphy JF, Twomey A, O' Donnell CP, Murphy NP, Molloy EJ. Vitamin D nutritional status in preterm infants and response to supplementation. Br J Nutr. 2013 Jul 14;110(1):156-63. doi: 10.1017/S0007114512004722. Epub 2012 Nov 27.

    PubMed 23182428

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cholecalciferol 400, Cholecalciferol 800 and Cholecalciferol 1200 in people with Infant, Premature, Diseases, run by Centre of Postgraduate Medical Education at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Magdalena Zarlenga, MD (+48224851171, magda.cmkp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum 25OHD levels in cord blood in Polish preterm infants (time frame: day of labour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03691896, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in