The effects of systemic vitamin D administration on production of interleukin-10 by peripheral blood T cells in asthmatics and controls. - Vitamin D Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002569-19-GB

Enrollment

Registered

2005-02-17

Start date

2004-12-15

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This trial is being conducted to test the hypothesis that short-term systemic administration of calcitriol in standard therapeutic dosages increases interleukin-10 production by peripheral blood T-cells in subjects with asthma, using healthy subjects as a control group.

Interventions

Trade Name: Calcitriol Product Name: Alfacalcidol Product Code: 0043/0052 Pharmaceutical Form: Capsule* INN or Proposed INN: 1.25-dihydroxycholecalciferol CAS Number: Not known Current Sponsor code: N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must be aged between 18-65 years and willing and able to give signed consent. Mild Asthmatics: Methacholine PC20 80% predicted Steroid-resistant asthmatics Never smokers No improvement in FEV1 post 2-week systemic steroid trial FEV1>40% predicted Healthy: Methacholine PC20 >16mg/ml Non-atopic FEV1 >80% predicted Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Existing pregnancy or breast-feeding. Subjects with existing hypercalcaemia. Subjects with significant renal impairment (plasma creatinine in excess of normal range). Subjects with existing systemic corticosteriod or therapy with any vitamin D analogue.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether short-term, systemic administration of calcitriol in standard therapeutic dosages increases IL-10 (interleukin - 10) production by peripheral blood T cells;Secondary Objective: None identified;Primary end point(s): To examine whether short-term, systemic administration of calcitriol in standard therapeutic dosages increases IL-10 production by peripheral blood T cells.	—

Measure

Time frame

Main Objective: To determine whether short-term, systemic administration of calcitriol in standard therapeutic dosages increases IL-10 (interleukin - 10) production by peripheral blood T cells;Secondary Objective: None identified;Primary end point(s): To examine whether short-term, systemic administration of calcitriol in standard therapeutic dosages increases IL-10 production by peripheral blood T cells.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026