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Cochrane Database of Systematic Reviews

Administración de suplementos de vitamina K para la fibrosis quística

Esta versión no es la más reciente

ver la versión actual 04 junio 2020

Información

DOI:
https://doi.org/10.1002/14651858.CD008482.pub5Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 22 agosto 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Fibrosis quística y enfermedades genéticas

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Vanitha A Jagannath

    Correspondencia a: Department of Paediatrics, American Mission Hospital, Manama, Bahrain

    [email protected]

    [email protected]

  • Vidhu Thaker

    Department of Medicine, Boston Children's Hospital, Boston, USA

  • Anne B Chang

    Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Australia

  • Amy I Price

    Research and Development, Empower 2 Go, Edmonton, UK

Contributions of authors

VJ, ZF and VT were responsible for:

  • organising the retrieval of papers;

  • writing to authors of papers for additional information;

  • screening search results;

  • screening retrieved papers against inclusion criteria;

  • appraising the quality of papers;

  • data collection for the review;

  • extracting data from papers; and

  • obtaining and screening data on unpublished trials;

  • the analysis and interpretation of data.

VJ and VT were responsible for :

  • designing the review;

  • co‐ordinating the review;and

  • data extraction and management for the review.

All review authors contributed to writing the review.
VJ conceived the idea for the review and is the guarantor of the review.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • National Health and Medical Research Council, Australia.

    Support for AC (Practitioner Fellowship grant number 545216)

  • NIH training grant, USA.

    Training grant T32DK007699/DK/NIDDK awarded to Vidhu Thaker.

Declarations of interest

Anne Chang declares she has received a grant provided by GSK which is unrelated to this topic. She is also the principal investigator on a study examining azithromycin for bronchiolitis in Indigenous children.

The remaining authors declare no financial conflicts of interest and that they do not have any associations with any parties who may have vested interests in the results of this review.

Acknowledgements

The authors would like to thank Nikki Jahnke of the Cochrane Cystic Fibrosis and Genetic Disorders Group for her support throughout this review.

We would also like to thank Professor Zbys Fedorowicz for his contributions to the review from its inception up to the update in 2017.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Cystic Fibrosis and Genetic Disorders Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2020 Jun 04

Vitamin K supplementation for cystic fibrosis

Review

Vanitha A Jagannath, Vidhu Thaker, Anne B Chang, Amy I Price

https://doi.org/10.1002/14651858.CD008482.pub6

2017 Aug 22

Vitamin K supplementation for cystic fibrosis

Review

Vanitha A Jagannath, Vidhu Thaker, Anne B Chang, Amy I Price

https://doi.org/10.1002/14651858.CD008482.pub5

2015 Jan 18

Vitamin K supplementation for cystic fibrosis

Review

Vanitha A Jagannath, Zbys Fedorowicz, Vidhu Thaker, Anne B Chang

https://doi.org/10.1002/14651858.CD008482.pub4

2013 Apr 30

Vitamin K supplementation for cystic fibrosis

Review

Vanitha A Jagannath, Zbys Fedorowicz, Vidhu Thaker, Anne B Chang

https://doi.org/10.1002/14651858.CD008482.pub3

2011 Jan 19

Vitamin K supplementation for cystic fibrosis

Review

Vanitha A Jagannath, Zbys Fedorowicz, Vidhu Thaker, Anne B Chang

https://doi.org/10.1002/14651858.CD008482.pub2

2010 Apr 14

Vitamin K supplementation for cystic fibrosis

Protocol

Vanitha A Jagannath, Zbys Fedorowicz, Vidhu Thaker, Anne B Chang, Nutayla Al‐Harthy

https://doi.org/10.1002/14651858.CD008482

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adolescent; Adult; Child; Humans;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Comparison of 1 mg/day vs 5 mg/day oral vitamin K, Outcome 1 Serum undercarboxylated osteocalcin levels.
Figuras y tablas -
Analysis 1.1

Comparison 1 Comparison of 1 mg/day vs 5 mg/day oral vitamin K, Outcome 1 Serum undercarboxylated osteocalcin levels.

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Comparison 1 Comparison of 1 mg/day vs 5 mg/day oral vitamin K, Outcome 2 Serum vitamin K levels.
Figuras y tablas -
Analysis 1.2

Comparison 1 Comparison of 1 mg/day vs 5 mg/day oral vitamin K, Outcome 2 Serum vitamin K levels.

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Table 3. Research recommendations based on a gap in the evidence on Vitamin K supplementation for cystic fibrosis

Core elements

Issues to consider

Status of research for this review

Evidence
(E)

What is the current state of evidence?

A systematic review found only limited high quality evidence in relation to the effectiveness or otherwise of vitamin K supplementation for people with CF.

Population
(P)

Diagnosis, disease stage, comorbidity, risk factor, sex, age, ethnic group, specific inclusion or exclusion criteria, clinical setting

Any age group with a diagnosis of CF (defined by sweat test or genetic testing or both). Pancreatic insufficient.

Intervention
(I)

Type, prognostic
factor

All preparations of vitamin K used as a supplement at any dose and for any duration.

Comparison
(C)

Type, prognostic factor

Placebo with a dose, frequency, duration comparable to the intervention, or no supplementation.
Trials comparing different doses and dose regimens of vitamin K will also be considered.
Compliance to be recorded via pill counts and any concomitant medications.

Outcome
(O)

Which clinical or patient related outcomes will the researcher need to measure, improve, influence or accomplish?
Which methods of measurement should be used?

Clinical outcomes related to:

  • coagulopathy

  • bone formation ie bone mineral density, DEXA scans

  • nutritional parameters; weight, height, BMI

Biochemical analysis:

  • serum levels: serum ucOC/cOC ratio

  • vitamin K‐specific laboratory outcomes: plasma level of vitamin K1 (measured by HPLC), PIVKA II levels (measured by ELISA)

Quality of life:

Adverse events

Data type: continuous and dichotomous

Time stamp
(T)

Date of literature search or recommendation

15 April 2010.

Study type

What is the most appropriate study design to address the proposed question?

RCT (adequately powered/large sample size, sufficient duration)
Methods: concealment of allocation sequence
Blinding: participants and investigators, but if not feasible then outcomes assessors and data analysts should be blinded.
Setting: CF Clinic

BMI: body mass index
CF: cystic fibrosis
cOC: carboxylated osteocalcin
DEXA: dual energy X‐ray absorptiometry
ELISA: enzyme‐linked immunosorbent assay
HPLC: high performance liquid chromatography
PIVKA‐II: proteins induced by vitamin K absence or antagonism factor II
RCT: randomised controlled trial
ucOC: undercarboxylated osteocalcin

Figuras y tablas -
Table 3. Research recommendations based on a gap in the evidence on Vitamin K supplementation for cystic fibrosis
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Table 1. Serum undercarboxylated osteocalcin (ucOC) percentage (Drury 2008)

Dose

n

UcOC %
Baseline mean (SD)

UcOC %
End of study mean (SD)

1 mg/day

7

46 (14.4)

28 (8.26)

5 mg/day

6

47.6 (9.45)

30.2 (13.09)

SD: standard deviation
ucOC: undercarboxylated osteocalcin

Figuras y tablas -
Table 1. Serum undercarboxylated osteocalcin (ucOC) percentage (Drury 2008)
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Table 2. Serum vitamin K levels (Drury 2008)

Dose

n

Serum vitamin K levels (nmol/L)
Baseline mean (SD)

Serum vitamin K levels (nmol/L)
End of study mean (SD)

1 mg/day

7

0.28 (0.25)

2.52 (2.61)

5 mg/day

6

0.15 (0.19)

6.98 (9.95)

SD: standard deviation
Figuras y tablas -
Table 2. Serum vitamin K levels (Drury 2008)
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Comparison 1. Comparison of 1 mg/day vs 5 mg/day oral vitamin K

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Serum undercarboxylated osteocalcin levels Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2 Serum vitamin K levels Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Comparison of 1 mg/day vs 5 mg/day oral vitamin K
Ir a la tabla de la revisión