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The effects of low dose 1,25-dihydroxyvitamin D3 on the polarising of cellular immune reactivity towards type 2 immunity.

The effects of 1,25-dihydroxyvitamin D3 on immune reactivity towards type 2 immunity.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29360
Enrollment
24
Registered
2006-08-10
Start date
2006-11-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

auto-immune diseases

Interventions

Twelve volunteers will receive 10 capsules of 0,5 µg calcitriol, the other twelve volunteers will receive 10 capsules placebo. They have to take the medication twice a day during 5 days.

Sponsors

dr. E.M.W. Eekhoff endocrinology Vu university medical centre De Boelelaan 1118 1081 HV Netherlands Tel:+31-20-4440533 Fax:+31-20-4440502 emw.eekhoff@vumc.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent; 2. women, aged 20-30 years; 3. use of oral contraception with estrogen and progestin; 4. apparently health.

Exclusion criteria

Exclusion criteria: 1. Men; 2. pregnancy; 3. smoking; 4. alcohol abuse: > 3 Units/day; 5. use of drugs, except for incidental analgesic agents; 6. use of diuretic medication or corticosteroids; 7. auto immune diseases; 8. renal impairment (serum creatinine >150 µmol/l); 9. malignant disease; 10. kidney-stones (also when this occurs in the family), urinary tract infections; 11. infectious diseases; 12. use of antibiotics; 13. use of any medication that influence T- lymphocytes or vitamin D metabolism; 14. disease or use of any medication known to affect Ca metabolism or skeletal physiology; 15. serious mental impairment i.e. preventing to understand the study protocol/aim.

Design outcomes

Primary

MeasureTime frame
We expect the serum level of 1,25(OH)2D3 to rise and to induce the activity of T lymphocytes and the dendritic cells which regulate the immunity and reduce the activity of type 1 T lymphocytes involved in auto-immune diseases. Their activity will be measured by the decrease of interferon gamma production.

Secondary

MeasureTime frame
We expect the type 1 cytokines to be decreased and the type 2 cytokines to be upregulated.

Contacts

Public ContactC.M. Dinkgreve

VU University Medical Center, Department of endocrinology De Boelelaan 1118

cm.dinkgreve@vumc.nl+31(0)20 4440533

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)