HypogonadismPhase 4NCT01748370
Vitamin D Treatment and Hypogonadism in Men
A Phase 4 study testing Vitamin D supplementation in hypogonadal men and Vitamin D supplementation in eugonadal men in people with Hypogonadism, run by Medical University of Graz at 1 site in Austria.
Trial summary
Low total testosterone (TT) is present in about 30% of men aged >60 years and in up to 7% of younger men. Male hypogonadism is associated with metabolic and cardiovascular diseases as well as with increased mortality. There is evidence showing a relationship of TT with vitamin D in men. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Vitamin D supplementation in hypogonadal men and Vitamin D supplementation in eugonadal men
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2012to 12 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- TT levels below 3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
- 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
- Male, age of ≥ 18 and <70 years
- Written informed consent before entered into study
- TT levels ≥3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
- 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
- Male, age of ≥ 18 and <70 years
- Written informed consent before entered into study
Who cannot join
- - Hypercalcemia defined as a serum calcium > 2,7 mmol/L
- Oral or transdermal testosterone supplementation in the last 2 months before entering the study
- IM testosterone supplementation 6 months before entering the study
- Regular intake of vitamin D supplements before study entry
- Men with chronic diseases (such as diabetes mellitus, thyroid disease, endocrine disturbances in need of treatment (except hypogonadism), or diseases known to interfere with vitamin D intake or very sensitive to vitamin D intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Mb Wegener, vasculitis, inflammatory bowel disease
- Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, insulin, glucocorticoids,…) in the last 3 months before study entry
Show all 27Show fewer
- PSA >4 ng/ml (or >3 ng/ml in men at high risk for prostate cancer) (see state of the art)
- Palpable prostate nodule or induration
- Hematocrit >50%
- Untreated severe obstructive sleep apnea
- Severe lower urinary tract symptoms
- Uncontrolled or poorly controlled heart failure
- A history of prostate cancer, breast cancer, orchidectomy, chromosomal disorders (e.g. Klinefelter Syndrome)
- Eugonadal men:
- Hypercalcemia defined as a serum calcium > 2,7 mmol/L
- Oral or transdermal testosterone supplementation in the last 2 months before entering the study
- IM testosterone supplementation 6 months before entering the study
- Regular intake of vitamin D supplements before study entry
- Men with chronic diseases (such as diabetes mellitus, endocrine disturbances in need of treatment (except hypogonadism), or diseases known to interfere with vitamin D intake or very sensitive to vitamin D intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Mb Wegener, vasculitis, inflammatory bowel disease
- Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, insulin, glucocorticoids,…) in the last 3 months before study entry
- PSA >4 ng/ml (or >3 ng/ml in men at high risk for prostate cancer) (see state of the art)
- Palpable prostate nodule or induration
- Hematocrit >50%
- Untreated severe obstructive sleep apnea
- Severe lower urinary tract symptoms
- Uncontrolled or poorly controlled heart failure
- A history of prostate cancer, breast cancer, orchidectomy, chromosomal disorders (e.g. Klinefelter)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
Graz, 8036
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Androgen Levels in Hypogonadal Men
Low total testosterone (TT) is present in about 30% of men aged >60 years and in up to 7% of younger men. Male hypogonadism is associated with metabolic and cardiovascular diseases as well as with increased mortality. There is evidence showing a relationship of TT with vitamin D in men. We aim at evaluating the effect of vitamin D supplementation on TT and metabolic parameters in hypogonadal men. We will study the effects of 20,000 IU vitamin D weekly in a 12 wk randomized, double-blind, placebo-controlled trial in 100 men with TT <3.0 ng/ml and 25-hydroxyvitamin D (25(OH)D) <30 ng/ml (patients) as well as in 100 men with TT ≥3.0 ng/ml and 25(OH)D <30 ng/ml (controls). Vitamin D supplementation might be a safe therapeutic approach improving TT levels as well as metabolic parameters in hypogonadal men. Further the effects of vitamin D on androgens will be evaluated in eugonadal men.
- Conditions
- Hypogonadism
- Being tested
- Vitamin D supplementation in hypogonadal men, Vitamin D supplementation in eugonadal men, Placebo hypogonadal, Placebo eugonadal
- Keywords
- vitamin D, hypogonadism, testosterone, intervention
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementation in hypogonadal menDrug
Also called A11CC05 Colecalciferol
Vitamin D supplementation in eugonadal menDrug
Also called A11CC05 Colecalciferol
Placebo hypogonadalDrug
Placebo eugonadalDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D hypogonadal | Experimental | Vitamin D supplementation in hypogonadal men Receives: Drug: Vitamin D supplementation in hypogonadal men |
| Vitamin D eugonadal | Experimental | Vitamin D supplementation in eugonadal men Receives: Drug: Vitamin D supplementation in eugonadal men |
| Placebo hypogonadal | Placebo comparator | Vitamin D supplementation in hypogonadal men Receives: Drug: Placebo hypogonadal |
| Placebo eugonadal | Placebo comparator | Vitamin D supplementation in eugonadal men Receives: Drug: Placebo eugonadal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total testosterone (TT)
Measured: Change from baseline in TT at 12 weeks
Secondary outcomes (5)
Free testosterone (FT)
Measured: Change from baseline in FT after 12 weeks
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Measured: Change from baseline in HOMA-IR at 12 weeks
Lipid levels (total cholesterol)
Measured: Change from baseline in total cholesterol at 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc
Measured: Change from Baseline in AUCgluc at 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins
Measured: Change from Baseline in AUCins at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study start1 Dec 2012
- Primary completion12 Nov 2017
- Study completion12 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lerchbaum Elisabeth, MD, Medical University of Graz
- Investigators
- Elisabeth Lerchbaum, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748370
- Sponsor's protocol ID
- VitDTesto1.0
- Other IDs
- 14846
- Status last verified
- Mar 2018
- First submitted
- 10 Dec 2012
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lerchbaum E, Pilz S, Trummer C, Schwetz V, Pachernegg O, Heijboer AC, Obermayer-Pietsch B. Vitamin D and Testosterone in Healthy Men: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4292-4302. doi: 10.1210/jc.2017-01428.
PubMed 28938446
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Androgen Levels in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT01748370
- Acronym / sponsor ID
- VitDTesto1.0
- Conditions
- Hypogonadism
- Keywords
- vitamin D, hypogonadism, testosterone, intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 12 Nov 2017 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low total testosterone (TT) is present in about 30% of men aged >60 years and in up to 7% of younger men. Male hypogonadism is associated with metabolic and cardiovascular diseases as well as with increased mortality. There is evidence showing a relationship of TT with vitamin D in men. We aim at evaluating the effect of vitamin D supplementation on TT and metabolic parameters in hypogonadal men. We will study the effects of 20,000 IU vitamin D weekly in a 12 wk randomized, double-blind, placebo-controlled trial in 100 men with TT <3.0 ng/ml and 25-hydroxyvitamin D (25(OH)D) <30 ng/ml (patients) as well as in 100 men with TT ≥3.0 ng/ml and 25(OH)D <30 ng/ml (controls). Vitamin D supplementation might be a safe therapeutic approach improving TT levels as well as metabolic parameters in hypogonadal men. Further the effects of vitamin D on androgens will be evaluated in eugonadal men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D hypogonadal | Experimental | Drug: Vitamin D supplementation in hypogonadal menVitamin D supplementation in hypogonadal men |
| Vitamin D eugonadal | Experimental | Drug: Vitamin D supplementation in eugonadal menVitamin D supplementation in eugonadal men |
| Placebo hypogonadal | Placebo comparator | Drug: Placebo hypogonadalVitamin D supplementation in hypogonadal men |
| Placebo eugonadal | Placebo comparator | Drug: Placebo eugonadalVitamin D supplementation in eugonadal men |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- TT levels below 3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
- 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
- Male, age of ≥ 18 and <70 years
- Written informed consent before entered into study
- TT levels ≥3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1)
Key exclusion criteria (27 listed)
- - Hypercalcemia defined as a serum calcium > 2,7 mmol/L
- Oral or transdermal testosterone supplementation in the last 2 months before entering the study
- IM testosterone supplementation 6 months before entering the study
- Regular intake of vitamin D supplements before study entry
- Men with chronic diseases (such as diabetes mellitus, thyroid disease, endocrine disturbances in need of treatment (except hypogonadism), or diseases known to interfere with vitamin D intake or very sensitive to vitamin D intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Mb Wegener, vasculitis, inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplementation in hypogonadal menAlso: A11CC05 Colecalciferol | Drug | Vitamin D hypogonadal |
| Vitamin D supplementation in eugonadal menAlso: A11CC05 Colecalciferol | Drug | Vitamin D eugonadal |
| Placebo hypogonadal | Drug | Placebo hypogonadal |
| Placebo eugonadal | Drug | Placebo eugonadal |
Primary outcome
Total testosterone (TT)
Time frame: Change from baseline in TT at 12 weeks
5 secondary outcomes
Free testosterone (FT)
Time frame: Change from baseline in FT after 12 weeks
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Time frame: Change from baseline in HOMA-IR at 12 weeks
Lipid levels (total cholesterol)
Time frame: Change from baseline in total cholesterol at 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc
Time frame: Change from Baseline in AUCgluc at 12 weeks
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCins
Time frame: Change from Baseline in AUCins at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Derived from this study: PubMed 28938446Lerchbaum E, Pilz S, Trummer C, Schwetz V, Pachernegg O, Heijboer AC, Obermayer-Pietsch B. Vitamin D and Testosterone in Healthy Men: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4292-4302. doi: 10.1210/jc.2017-01428.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Lerchbaum, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D supplementation in hypogonadal men and Vitamin D supplementation in eugonadal men in people with Hypogonadism, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total testosterone (TT) (time frame: Change from baseline in TT at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.