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Vitamin D supplementation and male infertility: a randomized double blinded clinical trial

Phase 1
Conditions
Male infertility
MedDRA version: 12.1Level: LLTClassification code 10021929Term: Infertility male
Registration Number
EUCTR2010-024588-42-DK
Lead Sponsor
Rigshospitalet
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Male
Target Recruitment
340
Inclusion Criteria

Male infertility
semen concentration < 20 mio./ml or <40 progressive motility, or < 7% morphologically normal sperm.
VD serum level < 50 nM
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

hypercalcaemia
Spontaneous intake 15 microrgram daily
disease with granuloma
indication of testicular biopsy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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