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

Prior treatment

• Any supplementation containing vitamin D alone or in combination within 2 months before the screening visit and during the study
• The use of medications affecting bone turnover (cholecalciferol, vitamin K, bisphosphonates, anti-epileptic medication, corticosteroid use, heparin)

Other illness

• Known bone disease (osteoporosis, Paget disease, primary hyperparathyroidism)
• Chronic liver failure defined as GOT/GPT > 2N
• A history of orchidectomy

Lab values

• Chronic renal failure defined as eGFR less than 60 mL/min/1.73 m2 for three or more months
• Hypocalcaemia defined as calcium levels below lower limit of normal range < 2.10 mmol/L
• Hypomagnesaemia defined as magnesium < 0.65 mmol/L
• Hypoalbuminemia defined as albumin < 3 g/dL
• Hypercalcemia defined as > 2.55 mmol/L

Other

• The use of Testosteron supplementation
• BMI > 40 Kg/m²
• Neuroleptic treatment

• Vitamin D < 75 nmol/L
• Caucasian men
• Age: 18 - 65 years
• BMI < 40 kg/m²
• Type 2 diabetes mellitus
• HbA1c ≤ 64 mmol/mol, ( 8%)
• Total testosteron < 11nmol/L