Vitamin D Deficiency Clinical Trial
Official title:
Effects of Vitamin D on Human Sperm DNA Fragmentation
The purpose of this study will be to investigate if there is a correlation between Vitamin D levels and Sperm DNA Fragmentation. This is a prospective, cohort study. In this study male participants presenting with their partners because of inability to conceive will be recruited for this study. Participants will have a blood sample drawn which will be tested for Vitamin D level. The investigators will then compare sperm DNA fragmentation between normal Vitamin D levels, Vitamin D insufficiency, and Vitamin D deficiency. All infertile males who present to the investigators' infertility clinic have a Semen analysis and Sperm chromatin Structure Assay (SCSA). The research part of the study will be to obtain the Vitamin D level.
Vitamin D plays an important role in bone metabolism and has also been discovered to
influence male reproduction. Vitamin D binds to the Vitamin D receptor which then can bind to
Vitamin D response elements in the DNA which can alter transcription. By changing
transcription it can have long term effects on cellular metabolism. Previous studies have
demonstrated abnormalities in sperm motility and morphology in males who are Vitamin D
deficient. The mechanism by which Vitamin D affects spermatogenesis (formation of sperm) is
unknown. One possibly mechanism by which deficient Vitamin D may affect sperm formation is
through DNA fragmentation. The head of the sperm contains all the DNA. When a sperm cell is
made the DNA in the nucleus must be super compacted to accomplish sperm formation. To
sufficiently compact the DNA, first the DNA is 'turned off' and then very tightly wound (or
compacted) into toroids (like small tires) which are stacked one on top of another. During
this process of compaction the DNA will occasionally break or fragment. The egg can repair
the DNA fragmentation as long as there is not a large amount of breakage. If the DNA
fragmentation exceeds a certain amount then fertilization and early development of the embryo
may be adversely affected. DNA fragmentation can be tested by using the Sperm Chromatin
Structure Assay (SCSA), which the investigators currently measure in males who present with
their partners with infertility. Previous studies have suggested that the abnormalities in
sperm due to vitamin D deficiency may be related to increased DNA fragmentation. This study
will assist in understanding the cause of sperm abnormalities in subjects with Vitamin D
deficiency.
This is a prospective, cohort study. In this study male patients who present with inability
to conceive will be asked to be involved in this study. After agreement with the study, a
blood sample drawn which will be tested for Vitamin D level. The investigators will then
compare sperm DNA fragmentation between normal Vitamin D levels, Vitamin D insufficiency, and
Vitamin D deficiency. All infertile males presenting to the investigators' infertility clinic
have a Semen analysis and Sperm chromatin Structure Assay (SCSA). The research part of the
study will be to obtain the Vitamin D level.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04244474 -
Effect of Vitamin D Supplementation on Improvement of Pneumonic Children
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05459298 -
ViDES Trial (Vitamin D Extra Supplementation)
|
N/A | |
| Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
| Completed |
NCT04476511 -
The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules
|
Phase 3 | |
| Completed |
NCT03920150 -
Vitamin D 24'000 IU for Oral Intermittent Supplementation
|
Phase 3 | |
| Completed |
NCT03264625 -
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
|
Phase 2 | |
| Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
| Recruiting |
NCT05084248 -
Vitamin D Deficiency in Adults Following a Major Burn Injury
|
Phase 4 | |
| Completed |
NCT05506696 -
Vitamin D Supplementation Study
|
N/A | |
| Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
| Completed |
NCT03234218 -
Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
|
||
| Completed |
NCT02714361 -
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
N/A | |
| Completed |
NCT02906319 -
Vitamin D and HbA1c Levels in Diabetic Patients With CKD
|
N/A | |
| Completed |
NCT03203382 -
Corneal Nerve Structure in Sjogren's
|
||
| Completed |
NCT02118129 -
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
|
N/A | |
| Completed |
NCT02187146 -
The Effects of Serum Vitamin D and IVF Outcome
|
N/A | |
| Not yet recruiting |
NCT01419821 -
Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5
|
N/A | |
| Completed |
NCT02275650 -
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
|
N/A | |
| Completed |
NCT01688102 -
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
|
N/A | |
| Completed |
NCT01741181 -
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2
|
Phase 4 |