vitamin d intake in type 2 diabetic male patients: can it increase free testosterone? a clinical trial placebo -controlled (non active similar looking product as vitamin D)

Vitamin D Supplementation to increase free testosterone in Type 2 Diabetes Mellitus men: a Placebo-controlled Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001751-12-BE

Enrollment

100

Registered

2018-10-11

Start date

2018-12-05

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

type 2 diabetes testosteron < 11 nmol/L

Interventions

Trade Name: d cure Pharmaceutical Form: Concentrate for oral solution INN or Proposed INN: BE461173 Other descriptive name: CHOLECALCIFEROL CONCENTRATE Concentration unit: IU/ml international unit(s)/

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Key inclusion criteria • Caucasian men • age: 18 - 65 years • BMI =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Key exclusion criteria • Chronic renal failure defined as eGFR less than 60 mL/min/1.73 m2 for three or more months • Chronic liver failure GOT/GPT 40 Kg/m² • Neuroleptic treatment Known bone disease (osteoporosis, Paget diseas, primary hyper parathyroid)

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective: To increase low free testosterone in men with T2D by vit D suppletion Evaluation the effect of vitamin D supplementation on the free testosterone level in men with type 2 diabetes and low testosterone level. ;Secondary Objective: Secondary objectives: a. Influence of bone on glucose hemostasis by measuring osteocalcin and insulin resistance (Mathematical HOMA) , pre and post study period b. Clinical effect on libido by validated questionnaires c. Is the increased level of testosterone either dependent or independent of the osteocalcin variation ;Primary end point(s): The primary endpoint of the study will be the (change) in free testosterone concentration after 10 days and 3 months. ;Timepoint(s) of evaluation of this end point: after 10 days and 3 months.	—

Measure

Time frame

Main Objective: Primary objective: To increase low free testosterone in men with T2D by vit D suppletion Evaluation the effect of vitamin D supplementation on the free testosterone level in men with type 2 diabetes and low testosterone level. ;Secondary Objective: Secondary objectives: a. Influence of bone on glucose hemostasis by measuring osteocalcin and insulin resistance (Mathematical HOMA) , pre and post study period b. Clinical effect on libido by validated questionnaires c. Is the increased level of testosterone either dependent or independent of the osteocalcin variation ;Primary end point(s): The primary endpoint of the study will be the (change) in free testosterone concentration after 10 days and 3 months. ;Timepoint(s) of evaluation of this end point: after 10 days and 3 months.

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary endpoints are: see above • Changes from baseline to 10 days and 3 months in total osteocalcin concentration • Proportion of participants with a low total testosterone level (<11 nmol/L) in the active treatment arm (vitamin D) compared to the placebo group one year after intervention. • Mean change from baseline to 3 months in glucose concentration using A1c • Clinical effect on libido by validated questionnaires ;Timepoint(s) of evaluation of this end point: after 10 days and 3 months	—

Measure

Time frame

Secondary end point(s): Key secondary endpoints are: see above • Changes from baseline to 10 days and 3 months in total osteocalcin concentration • Proportion of participants with a low total testosterone level (<11 nmol/L) in the active treatment arm (vitamin D) compared to the placebo group one year after intervention. • Mean change from baseline to 3 months in glucose concentration using A1c • Clinical effect on libido by validated questionnaires ;Timepoint(s) of evaluation of this end point: after 10 days and 3 months

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Countries

Belgium

Contacts

Public Contactdiabetes clinic

uz brussels

christophe.ghys@uzbrussel.be3224777760

Outcome results

None listed

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