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

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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

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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
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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
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Comparison 1. Comparison of 1 mg/day vs 5 mg/day oral vitamin K
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