erectile dysfunction patients with normal or abnormal vitamin D level whom visited at outpatient department of urology,
Conditions
Interventions
fasting blood sugar,
complete blood count,
PSA,
serum 25 hydroxy vitamin D level,
serum calcium level,
serum albumin level and serum creatinine
3. randomize into two group : experimental group and controlled group
4. every patients in two group will be received real sildenafil 100 mg,
2 tablet per month
5. Dose of vitamin D will be given depend on baseline vitamin D level of patient
5.1) 25 hydroxy vitamin D 30 ng/ml will be received vitamin D2(20,
000 unit) 1 capsule per week for 12 week
6. follow up 2 times
6.1) follow up by telephone at 1 month,
ask about international index of erectile function(IIEF5) and erectile hardness score
6.2) follow up at OPD 3 month,
ask about international index of erectile function(IIEF5),
erectile hardness score and repeat laboratory test including serum 25 hydroxy vitamin D level,
serum albumin level and serum creatinine,same as experimental group but use placebo drug that identical to the real one
dosage will depend on baseline vitamin D level as experimental
Experimental Drug,Placebo Comparator Drug
experimental vitamin D treatment group,placebo vitamin D treatment group
1. The participants will be inform about research and recruit as inclusion and exclusion criteria
2. The patients will be collected baseline data including basic demographic,
vital sign,
international index of erectile function(IIEF5),
erectile hardness score and baseline laboratory including testosterone level,
lipid profile,
Sponsors
faculty of medicine ramathibodi hospital, mahidol university, Thailand
Eligibility
Sex/Gender
Male
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Erectile dysfunction patients with IIEF 5 score < 21 2. patient's willing to be including in this trial
Exclusion criteria
Exclusion criteria: 1. patients who already have vitamin D supplement prior to trial 2. patients who have bowel disease that disturb drug absorption including celiac disease, Crohn disease, cystic fibrosis 3. patients who have drug or alcohol addiction 4. patients who have psychosis 5. patients who have CKD stage 4,5 6. patients who have acute illness that need hospitalization 7. patients who have contraindication for PDE5 inhibitor including 7.1 recent cardiiovascular or cerebrovascular or arrthymia in past 6 month 7.2 CHF NYHA class ≥ 2 or coronary a disease 7.3 BP drop or BP > 170/100 7.4 liver disease Child-Pugh score C or ESRD that need HD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erectile function 3 month IIEF 5 questionnaire, EHS questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Vitamin D level improvement 3 month 25 OH vitamin D level | — |
Countries
Thailand
Contacts
Public ContactTanawin Poopuangpairoj
faculty of medicine ramathibodi hospital, mahidol university, Thailand
Outcome results
None listed