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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024588-42-DK

Enrollment

340

Registered

2011-02-11

Start date

2011-02-10

Completion date

Unknown

Last updated

2016-09-05

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

Conditions

Male infertility MedDRA version: 12.1 Level: LLT Classification code 10021929 Term: Infertility male

Interventions

Trade Name: Cholecalciferol Product Name: cholecalciferol Product Code: A12 AX01 Pharmaceutical Form: Oral solution INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Current Sponsor code: auth

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male infertility semen concentration =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether vitamin D supplementation to vitamin D deficient or insufficient men improves semen quality and male fertility;Secondary Objective: Reproductive or sexhormones hormones Bone markers such as FGF23, osteocalcin, osteopontin, alkaline phsophatase, calcitonin, PTH, all circulating VD forms, calcium, klotho, procollagen and other bone markers ART or spontaneous pregnancy Percentage spermatozoa expressing cyp24a1 Composition of pH, HCO3, calcium, Zink, phosphat, vitamin D, FGF23, Klotho, osteocalcin, osteopontin Fat free mass, muscle, BMI, weight Serumlevels of Hb1Ac, cholesterol, lipids, indulin, adiponectin, c-peptid, HOMA, Insulin sensitivity, incretin hiórmones, GH, IGF, IGFBP-3, PSA , CEA, prolactin, cortisol, ACTH and copeptin Frequncy of infectious disease, acute phase reactants leucocytes, trombocytes, reticulocytes, complement, immunoglbulins, autoantibodies, ANA, antiphospholipid, reumafctor, factor 2,7,10. Change in lever enzymes (ALAT, ASAT, GGT, LDH), amylase, bilirubin, creatinin, albumin, carbamid, urat, creatininclearance, renin, aldosteron, angiotensinogen, B2-mikroglobulin, BNP, ANP ;Primary end point(s): change in semen quality and fertility potential	—

Measure

Time frame

Main Objective: To investigate whether vitamin D supplementation to vitamin D deficient or insufficient men improves semen quality and male fertility;Secondary Objective: Reproductive or sexhormones hormones Bone markers such as FGF23, osteocalcin, osteopontin, alkaline phsophatase, calcitonin, PTH, all circulating VD forms, calcium, klotho, procollagen and other bone markers ART or spontaneous pregnancy Percentage spermatozoa expressing cyp24a1 Composition of pH, HCO3, calcium, Zink, phosphat, vitamin D, FGF23, Klotho, osteocalcin, osteopontin Fat free mass, muscle, BMI, weight Serumlevels of Hb1Ac, cholesterol, lipids, indulin, adiponectin, c-peptid, HOMA, Insulin sensitivity, incretin hiórmones, GH, IGF, IGFBP-3, PSA , CEA, prolactin, cortisol, ACTH and copeptin Frequncy of infectious disease, acute phase reactants leucocytes, trombocytes, reticulocytes, complement, immunoglbulins, autoantibodies, ANA, antiphospholipid, reumafctor, factor 2,7,10. Change in lever enzymes (ALAT, ASAT, GGT, LDH), amylase, bilirubin, creatinin, albumin, carbamid, urat, creatininclearance, renin, aldosteron, angiotensinogen, B2-mikroglobulin, BNP, ANP ;Primary end point(s): change in semen quality and fertility potential

—

Countries

Denmark

Outcome results

None listed

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