Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-20
Brief Title:
Association of Vitamin D Level and Its Receptor With Endometriosis
Sponsor:
Khon Kaen University
Organization:
Khon Kaen University
Study Overview
Official Title:
Association of Vitamin D Level and Its Receptor With Endometriosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Endometriosis a condition where endometrial-like tissue grows outside the uterus often occurs due to retrograde menstruation where menstrual blood flows backward through the fallopian tubes into the pelvic cavity This tissue can then implant and grow within the pelvic peritoneum The survival of these ectopic implants leads to chronic inflammation adhesion formation and scarring of surrounding tissues including the ovaries and fallopian tubes Symptoms include cyclic pelvic pain dysmenorrhea dyspareunia and infertility
Ectopic endometrial tissue survival is not attributed to mutations but rather epigenetic changes Studies have linked this phenomenon to genes such as KRAS Kirsten Rat Sarcoma Virus Oncogene involved in cell proliferation and survival Dysregulated KRAS activity can lead to increased production of MMP-2 and MMP-9 proteins implicated in angiogenesis and tissue invasion facilitating the spread of endometrial tissue
Vitamin D has been shown to modulate immune function and reduce inflammation Studies suggest that vitamin D deficiency may exacerbate endometriosis symptoms and severity However evidence regarding the efficacy of vitamin D supplementation in managing endometriosis symptoms is mixed
One study found that long-term intake of vitamin D-rich foods was associated with an 18 lower risk of developing endometriosis Additionally vitamin D deficiency has been correlated with increased expression of mutated KRAS in colorectal cancer patients suggesting a potential link between vitamin D status and genetic abnormalities in disease progression
Further research is needed to fully understand the relationship between vitamin D deficiency and endometriosis severity particularly in specific populations like the Thai population
Ectopic endometrial tissue survival is not attributed to mutations but rather epigenetic changes Studies have linked this phenomenon to genes such as KRAS Kirsten Rat Sarcoma Virus Oncogene involved in cell proliferation and survival Dysregulated KRAS activity can lead to increased production of MMP-2 and MMP-9 proteins implicated in angiogenesis and tissue invasion facilitating the spread of endometrial tissue
Vitamin D has been shown to modulate immune function and reduce inflammation Studies suggest that vitamin D deficiency may exacerbate endometriosis symptoms and severity However evidence regarding the efficacy of vitamin D supplementation in managing endometriosis symptoms is mixed
One study found that long-term intake of vitamin D-rich foods was associated with an 18 lower risk of developing endometriosis Additionally vitamin D deficiency has been correlated with increased expression of mutated KRAS in colorectal cancer patients suggesting a potential link between vitamin D status and genetic abnormalities in disease progression
Further research is needed to fully understand the relationship between vitamin D deficiency and endometriosis severity particularly in specific populations like the Thai population
Detailed Description:
Endometriosis occurs when endometrial-like tissue grows outside the uterus typically within the pelvic cavity due to retrograde menstruation through the fallopian tube The survival and growth of these endometrial cells outside the uterus depend on estrogen leading to chronic inflammation and symptoms such as cyclic abdominal pain dyspareunia and infertility
The ectopic endometriotic tissue survival outside the uterus is not due to cell mutation but is associated with epigenetic changes Studies have found a correlation with the KRAS gene which controls cell division and abnormal KRAS function reduces cell death contributing to the development of ectopic endometriotic tissue This tissue can form in various pelvic locations including the ovarian follicles and the peritoneal cavity within the cul-de-sac
Vitamin D is beneficial for the body in several systems including the endocrine skeletal immune and nervous systems It is used to treat diseases related to the immune system and inflammation Patients with infections or autoimmune diseases often undergo vitamin D level testing and supplementation Vitamin D levels below 20 ngml indicate deficiency 30-50 ngml are considered normal and levels above 100 ngml are toxic Thai people are at risk of deficiency or insufficiency despite being in a region with ample sunlight exposure throughout the year primarily due to decreased sun exposure behavior Several studies have found higher rates of deficiency among Thai women compared to men with varied prevalence across different regions of Thailand
Studies in Asian countries including South Korea Malaysia and Vietnam have reported high rates of vitamin D deficiency In a study across 19 provinces in Vietnam over half of the women were deficient in vitamin D Vitamin D deficiency has been linked to various diseases including musculoskeletal disorders endocrine disorders malabsorption syndromes obesity chronic kidney disease cancer and central nervous system disorders Age does not seem to correlate with vitamin D levels Sunscreen use has not been shown to affect vitamin D levels
In Korea work-related factors have been found to influence vitamin D levels while body mass index BMI did not correlate with vitamin D levels However obesity has been associated with vitamin D deficiency in several studies including levels of blood lipids
Vitamin D and its receptor play crucial roles in cellular functions within the immune system reducing inflammation through various mechanisms Providing vitamin D to endometrial cells in culture can reduce the production of MMP-2 and MMP-9 proteins MicroRNA expression associated with the vitamin D receptor increased after vitamin D supplementation The expression of the vitamin D receptor assessed by immunohistochemical staining was significantly correlated with abnormal KRAS gene function in colorectal cancer patients Moreover increased expression was found in immunohistochemically stained tissue specimens of ectopic endometriotic tissue in untreated groups compared to those treated with progesterone before surgery In cultured endometriotic tissue vitamin D was found to reduce the production of MMP-2 and MMP-9 proteins leading to decreased inflammation
Vitamin D also inhibits the action of alpha estrogen receptor in breast cancer cells and both alpha and beta estrogen receptors are present in ectopic endometriotic tissue Alpha estrogen receptors are inhibited by progestin drugs used in treatment An increase in alpha estrogen receptor expression indicates disease progression Currently beta estrogen receptors are found to have a greater proportion and a more significant role in various diseases However studies have also shown that alpha estrogen receptors may play a role in the development of ectopic endometriotic tissue
The mechanisms by which vitamin D reduces MMPs and inhibits the action of alpha estrogen receptors are significant Prolonged chronic inflammation can lead to increased surgical complications or disease progression Surgical treatment for ectopic endometriotic tissue can help alleviate pain symptoms The severity of the disease following surgery is assessed using the revised American Society for Reproductive Medicine rASRM criteria considering factors such as lesion size adhesions ovarian lesions and fluid characteristics within lesions Studies have found a correlation between disease severity according to rASRM and abnormal KRAS gene function Abnormal KRAS stimulates the production of MMP-2 and MMP-9 proteins which are involved in angiogenesis cell invasion and the spread of cells Increased levels of MMP-2 and MMP-9 lead to the proliferation of ectopic endometriotic tissue High levels of MMP protein production have also been associated with resistance to progesterone treatment in endometriotic tissue cells
Although current studies on vitamin D treatment may show insignificant reduction in pain symptoms there are studies indicating that long-term consumption of high vitamin D foods can reduce the risk of developing ectopic endometriotic tissue by up to 18 Vitamin D levels also correlate with the risk of disease Deficiency or insufficiency of vitamin D over time may be a contributing factor to the growth of ectopic endometriotic tissue and may exacerbate the severity of the disease and associated pain symptoms compared to those with normal vitamin D levels Considering the impact of vitamin D deficiency on ectopic endometriotic tissue there are currently no studies investigating vitamin D levels in Thai individuals with more than half of them being deficient Therefore this study aims to determine whether there is a correlation between blood vitamin D levels and individuals in Thailand with ectopic endometriotic tissue
The ectopic endometriotic tissue survival outside the uterus is not due to cell mutation but is associated with epigenetic changes Studies have found a correlation with the KRAS gene which controls cell division and abnormal KRAS function reduces cell death contributing to the development of ectopic endometriotic tissue This tissue can form in various pelvic locations including the ovarian follicles and the peritoneal cavity within the cul-de-sac
Vitamin D is beneficial for the body in several systems including the endocrine skeletal immune and nervous systems It is used to treat diseases related to the immune system and inflammation Patients with infections or autoimmune diseases often undergo vitamin D level testing and supplementation Vitamin D levels below 20 ngml indicate deficiency 30-50 ngml are considered normal and levels above 100 ngml are toxic Thai people are at risk of deficiency or insufficiency despite being in a region with ample sunlight exposure throughout the year primarily due to decreased sun exposure behavior Several studies have found higher rates of deficiency among Thai women compared to men with varied prevalence across different regions of Thailand
Studies in Asian countries including South Korea Malaysia and Vietnam have reported high rates of vitamin D deficiency In a study across 19 provinces in Vietnam over half of the women were deficient in vitamin D Vitamin D deficiency has been linked to various diseases including musculoskeletal disorders endocrine disorders malabsorption syndromes obesity chronic kidney disease cancer and central nervous system disorders Age does not seem to correlate with vitamin D levels Sunscreen use has not been shown to affect vitamin D levels
In Korea work-related factors have been found to influence vitamin D levels while body mass index BMI did not correlate with vitamin D levels However obesity has been associated with vitamin D deficiency in several studies including levels of blood lipids
Vitamin D and its receptor play crucial roles in cellular functions within the immune system reducing inflammation through various mechanisms Providing vitamin D to endometrial cells in culture can reduce the production of MMP-2 and MMP-9 proteins MicroRNA expression associated with the vitamin D receptor increased after vitamin D supplementation The expression of the vitamin D receptor assessed by immunohistochemical staining was significantly correlated with abnormal KRAS gene function in colorectal cancer patients Moreover increased expression was found in immunohistochemically stained tissue specimens of ectopic endometriotic tissue in untreated groups compared to those treated with progesterone before surgery In cultured endometriotic tissue vitamin D was found to reduce the production of MMP-2 and MMP-9 proteins leading to decreased inflammation
Vitamin D also inhibits the action of alpha estrogen receptor in breast cancer cells and both alpha and beta estrogen receptors are present in ectopic endometriotic tissue Alpha estrogen receptors are inhibited by progestin drugs used in treatment An increase in alpha estrogen receptor expression indicates disease progression Currently beta estrogen receptors are found to have a greater proportion and a more significant role in various diseases However studies have also shown that alpha estrogen receptors may play a role in the development of ectopic endometriotic tissue
The mechanisms by which vitamin D reduces MMPs and inhibits the action of alpha estrogen receptors are significant Prolonged chronic inflammation can lead to increased surgical complications or disease progression Surgical treatment for ectopic endometriotic tissue can help alleviate pain symptoms The severity of the disease following surgery is assessed using the revised American Society for Reproductive Medicine rASRM criteria considering factors such as lesion size adhesions ovarian lesions and fluid characteristics within lesions Studies have found a correlation between disease severity according to rASRM and abnormal KRAS gene function Abnormal KRAS stimulates the production of MMP-2 and MMP-9 proteins which are involved in angiogenesis cell invasion and the spread of cells Increased levels of MMP-2 and MMP-9 lead to the proliferation of ectopic endometriotic tissue High levels of MMP protein production have also been associated with resistance to progesterone treatment in endometriotic tissue cells
Although current studies on vitamin D treatment may show insignificant reduction in pain symptoms there are studies indicating that long-term consumption of high vitamin D foods can reduce the risk of developing ectopic endometriotic tissue by up to 18 Vitamin D levels also correlate with the risk of disease Deficiency or insufficiency of vitamin D over time may be a contributing factor to the growth of ectopic endometriotic tissue and may exacerbate the severity of the disease and associated pain symptoms compared to those with normal vitamin D levels Considering the impact of vitamin D deficiency on ectopic endometriotic tissue there are currently no studies investigating vitamin D levels in Thai individuals with more than half of them being deficient Therefore this study aims to determine whether there is a correlation between blood vitamin D levels and individuals in Thailand with ectopic endometriotic tissue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None