NAFLDNCT06038253
Relation Between NAFLD and BM DENSITY
An observational study of NAFLD and Osteoporosis, run by Assiut University.
Trial summary
In general NAFLD is a common denominal for a broad spectrum of damage to the liver, which can be due to hepatocyte injury, inflammatory processes and fibrosis. This is normally seen on liver biopsy and can range from milder forms (steatosis) to the more severe forms (non-alcoholic steatohepatitis (NASH), advanced… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- NAFLD, Osteoporosis
- What is being tested?
- Fibroscan
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Adult
Study population: 1. Patients presented to obesity clinic for follow up 2. Patients presented to git clinic at Alrajhi hospital 3. Patients presented to fibroscan clinic for evaluation the degree of liver fibrosis and steatosis will be included in the study 4. Patients presented at radiology department for abd U.S and diagnosed accidentally fatty liver .
Who may be able to join
- INCLUSION CRITERIA
- Patients above the age of 18 y.o and premenopausal females
- Patients showing any degree of fibrosis and steatosis .
- Patients suffers from obesity and its complications
- Patients with hyperlipidemia and DM
- NAFLD patients were diagnosed with an ultrasound examination or fibroscan or pathological examination to make a clear and definite diagnosis,
- all the obese participants according to body mass index (BMI)
- BMD was measured by dual energy X-ray absorptiometry.
Who cannot join
- 1- Patients less than 18 y.o 2- Patients known alcohol abuser of ≥30 g/day in men or≥20 g/day in women. 3- Patients with chronic liver disease or HCC. 4- Subjects with suspected or proven any other liver disease other than NAFLD as (viral hepatitis, drug-induced liver injury, autoimmune liver disease, Wilson's disease or primary biliary cholangitis).
- 5- none of the subjects followed specific diets or therapeutic treatments that could influence BMD or liver function.
- 6- Patients with conditions known to affect bone metabolism, such as kidney, thyroid or parathyroid diseases, bone tumors 7- (iv) Postmenopausal females to avoid the increased risk of osteoporosis in those patients due to hormonal changes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Relation Between Non- Alcoholic Fatty Liver Disease and Bone Mineral Density in Egyptian Adults
In general NAFLD is a common denominal for a broad spectrum of damage to the liver, which can be due to hepatocyte injury, inflammatory processes and fibrosis. This is normally seen on liver biopsy and can range from milder forms (steatosis) to the more severe forms (non-alcoholic steatohepatitis (NASH), advanced fibrosis, cirrhosis and liver failure). In these patients, advanced fibrosis is the major predictor of morbidity and liver-related mortality, and an accurate diagnosis of NASH and NAFLD is mandatory .
NAFLD is closely associated with metabolic disorders, including central obesity, dyslipidaemia, hypertension, hyperglycaemia and persistent abnormalities of liver function tests. NAFLD was shown to be connected with diseases that are usually not dependent on obesity, such as sarcopenia and osteoporosis
Read more
Target of the study :
- Clarify predictive value of fibroscan and u/s in diagnosis of NAFLD.
- Estimate the metabolic effect of NAFLD on bone density
- Estimate the correlation between obesity , NAFLD and BMD
Read the detailed description
INTRODUCTION:
In general, the prevalence of NAFLD has increased over the last 20 years. The Middle East and South America have the highest NAFLD prevalence at 31% and 32% respectively with the lowest prevalence in Africa at 13.5% .
NAFLD is closely associated with metabolic disorders, including central obesity, dyslipidaemia, hypertension, hyperglycaemia and persistent abnormalities of liver function tests. NAFLD was shown to be connected with diseases that are usually not dependent on obesity, such as sarcopenia and osteoporosis In general NAFLD is a common denominal for a broad spectrum of damage to the liver, which can be due to hepatocyte injury, inflammatory processes and fibrosis. This is normally seen on liver biopsy and can range from milder forms (steatosis) to the more severe forms (non-alcoholic steatohepatitis (NASH), advanced fibrosis, cirrhosis and liver failure). In these patients, advanced fibrosis is the major predictor of morbidity and liver-related mortality, and an accurate diagnosis of NASH and NAFLD is mandatory .
Osteoporosis is a group of bone diseases with various causes, including general factors related to aging, obesity and sex steroid deficiency, as well as specific risk factors such as the use of glucocorticoids, reduced bone quality, and disruption of microarchitectural integrity. In most cases of osteoporosis, the reduction in bone tissue is mainly due to increased bone resorption. Osteoporosis is characterized by low bone mineral density (BMD), bone pain and easy fracture.Osteoporosis is a silent disease until fractures occur with increasing frequency, which can cause important problems and even death. In industrialized countries, 9%-38% of women and 1%-8% of men >50 years suffer from osteoporosis.
Therefore, osteoporosis is not only harmful to health but also increases the financial burden of the impacted countries.
Many studies have demonstrated that NAFLD is associated with low BMD and osteoporosis.
Liver is the source of many proteins and is the regulator of several pathways involving bone metabolism; one of the most well-known of all is vitamin D metabolism pathway. Considering the role of liver in bone metabolism, the association between NAFLD and bone abnormalities is not surprising especially with substantial supporting evidences in recent years .
Besides its role in the calcium and bone metabolism, vitamin D may also exert pleiotropic effects in many tissues. NAFLD patients were reported to have a marked reduction in serum 25(OH) vitamin D when compared with control Liver biopsy remains the current gold standard for diagnosis of NAFLD, despite limitations regarding sampling variability, invasive nature, and high cost. However, numerous non-invasive biomarkers, including mainly serum markers or imaging modalities, intend to detect the presence of steatosis, NASH or advanced fibrosis. To date, ultrasound is suggested as first-line screening tool for defining steatosis in a selected population, while diagnosis of NAFLD requires exclusion of other chronic liver disease etiology or other steatosis causes and exclusion of alcohol intake by history .
Fibro scan becomes an evidence based , transient elastography instrument For noninvasive evaluation of liver steatosis and fibrosis , fibroscan is becoming an increasing important modality in NAFLD practice , as it was recently used to identify patients eligible for NAFLD related clinical trials
Target of the study :
- Clarify predictive value of fibroscan and u/s in diagnosis of NAFLD.
- Estimate the metabolic effect of NAFLD on bone density
- Estimate the correlation between obesity , NAFLD and BMD
STUDY DESIGN :
CROSS- SECTIONAL OBSERVATIONAL STUDY
Patients and methods :
- Patients presented to obesity clinic for follow up
- Patients presented to git clinic
- Patients presented to fibroscan clinic for evaluation the degree of liver fibrosis and steatosis will be included in the study
- Patients presented at radiology department for abd U.S and diagnosed accidentally fatty liver .
INCLUSION CRITERIA
- Patients above the age of 18 y.o and premenopausal females
- Patients showing any degree of fibrosis and steatosis .
- Patients suffers from obesity and its complications
- Patients with hyperlipidemia and diabetes mellitus .
- NAFLD patients were diagnosed with an ultrasound examination or fibroscan or pathological examination to make a clear and definite diagnosis,
- all the obese participants according to body mass index (BMI)
- BMD was measured by dual energy X-ray absorptiometry.
Exclusion criteria :
- Patients less than 18 y.o
- Patients known alcohol abuser of ≥30 g/day in men or≥20 g/day in women.
- Patients with chronic liver disease or hepatocellular carcinoma .
- Subjects with suspected or proven any other liver disease other than NAFLD as (viral hepatitis, drug-induced liver injury, autoimmune liver disease, Wilson's disease or primary biliary cholangitis).
- none of the subjects followed specific diets or therapeutic treatments that could influence BMD or liver function.
- Patients with conditions known to affect bone metabolism, such as kidney, thyroid or parathyroid diseases, bone tumors
- (iv) Postmenopausal females to avoid the increased risk of osteoporosis in those patients due to hormonal changes.
- Conditions
- NAFLD, Osteoporosis
- Being tested
- Fibroscan
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDevice
Also called Dexa scan
Fibroscan is device to detect degree of liver fibrosis in NAFLD patients Dexa scan device detect degree of osteoporosis in NAFLD patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of vit D level in serum in NAFLD patients
To study level of vit D in NAFLD patients and its relation to disease severity
Measured: 1 year
Degree of osteoporosis in NAFLD patients
Using dexa scan to detect level of osteoporosis in NAFLD patients
Measured: 1 year
Level of parathyroid hormone level in NAFLD PATIENTS
Level of parathyroid hormone level in NAFLD PATIENTS and its relation to disease severity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina maged helmy habib, Assiut University
- Investigators
- Ghada Abdelrahman alkhateeb, Professor, Study director, Assiut UniversityAhmed Mohammed mostafa ashmawy, Assistant professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038253
- Sponsor's protocol ID
- NAFLD and bone mineral density
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sasso M, Audiere S, Kemgang A, Gaouar F, Corpechot C, Chazouilleres O, Fournier C, Golsztejn O, Prince S, Menu Y, Sandrin L, Miette V. Liver Steatosis Assessed by Controlled Attenuation Parameter (CAP) Measured with the XL Probe of the FibroScan: A Pilot Study Assessing Diagnostic Accuracy. Ultrasound Med Biol. 2016 Jan;42(1):92-103. doi: 10.1016/j.ultrasmedbio.2015.08.008. Epub 2015 Sep 19.
PubMed 26386476Ballestri S, Zona S, Targher G, Romagnoli D, Baldelli E, Nascimbeni F, Roverato A, Guaraldi G, Lonardo A. Nonalcoholic fatty liver disease is associated with an almost twofold increased risk of incident type 2 diabetes and metabolic syndrome. Evidence from a systematic review and meta-analysis. J Gastroenterol Hepatol. 2016 May;31(5):936-44. doi: 10.1111/jgh.13264.
PubMed 26667191Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.
PubMed 24042449Eshraghian A. Bone metabolism in non-alcoholic fatty liver disease: vitamin D status and bone mineral density. Minerva Endocrinol. 2017 Jun;42(2):164-172. doi: 10.23736/S0391-1977.16.02587-6. Epub 2016 Dec 14.
PubMed 27973461Poggiogalle E, Donini LM, Lenzi A, Chiesa C, Pacifico L. Non-alcoholic fatty liver disease connections with fat-free tissues: A focus on bone and skeletal muscle. World J Gastroenterol. 2017 Mar 14;23(10):1747-1757. doi: 10.3748/wjg.v23.i10.1747.
PubMed 28348479
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Non- Alcoholic Fatty Liver Disease and Bone Mineral Density in Egyptian Adults
- ClinicalTrials.gov ID
- NCT06038253
- Acronym / sponsor ID
- NAFLD and bone mineral density
- Conditions
- NAFLD, Osteoporosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Sep 2023 (actual)
- 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.
In general NAFLD is a common denominal for a broad spectrum of damage to the liver, which can be due to hepatocyte injury, inflammatory processes and fibrosis. This is normally seen on liver biopsy and can range from milder forms (steatosis) to the more severe forms (non-alcoholic steatohepatitis (NASH), advanced fibrosis, cirrhosis and liver failure). In these patients, advanced fibrosis is the major predictor of morbidity and liver-related mortality, and an accurate diagnosis of NASH and NAFLD is mandatory .
NAFLD is closely associated with metabolic disorders, including central obesity, dyslipidaemia, hypertension, hyperglycaemia and persistent abnormalities of liver function tests. NAFLD was shown to be connected with diseases that are usually not dependent on obesity, such as sarcopenia and osteoporosis
Target of the study :
- Clarify predictive value of fibroscan and u/s in diagnosis of NAFLD.
- Estimate the metabolic effect of NAFLD on bone density
- Estimate the correlation between obesity , NAFLD and BMD
Detailed description
INTRODUCTION:
In general, the prevalence of NAFLD has increased over the last 20 years. The Middle East and South America have the highest NAFLD prevalence at 31% and 32% respectively with the lowest prevalence in Africa at 13.5% .
NAFLD is closely associated with metabolic disorders, including central obesity, dyslipidaemia, hypertension, hyperglycaemia and persistent abnormalities of liver function tests. NAFLD was shown to be connected with diseases that are usually not dependent on obesity, such as sarcopenia and osteoporosis In general NAFLD is a common denominal for a broad spectrum of damage to the liver, which can be due to hepatocyte injury, inflammatory processes and fibrosis. This is normally seen on liver biopsy and can range from milder forms (steatosis) to the more severe forms (non-alcoholic steatohepatitis (NASH), advanced fibrosis, cirrhosis and liver failure). In these patients, advanced fibrosis is the major predictor of morbidity and liver-related mortality, and an accurate diagnosis of NASH and NAFLD is mandatory .
Osteoporosis is a group of bone diseases with various causes, including general factors related to aging, obesity and sex steroid deficiency, as well as specific risk factors such as the use of glucocorticoids, reduced bone quality, and disruption of microarchitectural integrity. In most cases of osteoporosis, the reduction in bone tissue is mainly due to increased bone resorption. Osteoporosis is characterized by low bone mineral density (BMD), bone pain and easy fracture.Osteoporosis is a silent disease until fractures occur with increasing frequency, which can cause important problems and even death. In industrialized countries, 9%-38% of women and 1%-8% of men >50 years suffer from osteoporosis.
Therefore, osteoporosis is not only harmful to health but also increases the financial burden of the impacted countries.
Many studies have demonstrated that NAFLD is associated with low BMD and osteoporosis.
Liver is the source of many proteins and is the regulator of several pathways involving bone metabolism; one of the most well-known of all is vitamin D metabolism pathway. Considering the role of liver in bone metabolism, the association between NAFLD and bone abnormalities is not surprising especially with substantial supporting evidences in recent years .
Besides its role in the calcium and bone metabolism, vitamin D may also exert pleiotropic effects in many tissues. NAFLD patients were reported to have a marked reduction in serum 25(OH) vitamin D when compared with control Liver biopsy remains the current gold standard for diagnosis of NAFLD, despite limitations regarding sampling variability, invasive nature, and high cost. However, numerous non-invasive biomarkers, including mainly serum markers or imaging modalities, intend to detect the presence of steatosis, NASH or advanced fibrosis. To date, ultrasound is suggested as first-line screening tool for defining steatosis in a selected population, while diagnosis of NAFLD requires exclusion of other chronic liver disease etiology or other steatosis causes and exclusion of alcohol intake by history .
Fibro scan becomes an evidence based , transient elastography instrument For noninvasive evaluation of liver steatosis and fibrosis , fibroscan is becoming an increasing important modality in NAFLD practice , as it was recently used to identify patients eligible for NAFLD related clinical trials
Target of the study :
- Clarify predictive value of fibroscan and u/s in diagnosis of NAFLD.
- Estimate the metabolic effect of NAFLD on bone density
- Estimate the correlation between obesity , NAFLD and BMD
STUDY DESIGN :
CROSS- SECTIONAL OBSERVATIONAL STUDY
Patients and methods :
- Patients presented to obesity clinic for follow up
- Patients presented to git clinic
- Patients presented to fibroscan clinic for evaluation the degree of liver fibrosis and steatosis will be included in the study
- Patients presented at radiology department for abd U.S and diagnosed accidentally fatty liver .
INCLUSION CRITERIA
- Patients above the age of 18 y.o and premenopausal females
- Patients showing any degree of fibrosis and steatosis .
- Patients suffers from obesity and its complications
- Patients with hyperlipidemia and diabetes mellitus .
- NAFLD patients were diagnosed with an ultrasound examination or fibroscan or pathological examination to make a clear and definite diagnosis,
- all the obese participants according to body mass index (BMI)
- BMD was measured by dual energy X-ray absorptiometry.
Exclusion criteria :
- Patients less than 18 y.o
- Patients known alcohol abuser of ≥30 g/day in men or≥20 g/day in women.
- Patients with chronic liver disease or hepatocellular carcinoma .
- Subjects with suspected or proven any other liver disease other than NAFLD as (viral hepatitis, drug-induced liver injury, autoimmune liver disease, Wilson's disease or primary biliary cholangitis).
- none of the subjects followed specific diets or therapeutic treatments that could influence BMD or liver function.
- Patients with conditions known to affect bone metabolism, such as kidney, thyroid or parathyroid diseases, bone tumors
- (iv) Postmenopausal females to avoid the increased risk of osteoporosis in those patients due to hormonal changes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- 1. Patients presented to obesity clinic for follow up 2. Patients presented to git clinic at Alrajhi hospital 3. Patients presented to fibroscan clinic for evaluation the degree of liver fibrosis and steatosis will be included in the study 4. Patients presented at radiology department for abd U.S and diagnosed accidentally fatty liver .
Key inclusion criteria (8 listed)
- INCLUSION CRITERIA
- Patients above the age of 18 y.o and premenopausal females
- Patients showing any degree of fibrosis and steatosis .
- Patients suffers from obesity and its complications
- Patients with hyperlipidemia and DM
Key exclusion criteria (3 listed)
- 1- Patients less than 18 y.o 2- Patients known alcohol abuser of ≥30 g/day in men or≥20 g/day in women. 3- Patients with chronic liver disease or HCC. 4- Subjects with suspected or proven any other liver disease other than NAFLD as (viral hepatitis, drug-induced liver injury, autoimmune liver disease, Wilson's disease or primary biliary cholangitis).
- 5- none of the subjects followed specific diets or therapeutic treatments that could influence BMD or liver function.
- 6- Patients with conditions known to affect bone metabolism, such as kidney, thyroid or parathyroid diseases, bone tumors 7- (iv) Postmenopausal females to avoid the increased risk of osteoporosis in those patients due to hormonal changes.
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 |
|---|---|---|
| FibroscanAlso: Dexa scanFibroscan is device to detect degree of liver fibrosis in NAFLD patients Dexa scan device detect degree of osteoporosis in NAFLD patients | Device | – |
Primary outcome
Level of vit D level in serum in NAFLD patients
Time frame: 1 year
To study level of vit D in NAFLD patients and its relation to disease severity
Degree of osteoporosis in NAFLD patients
Time frame: 1 year
Using dexa scan to detect level of osteoporosis in NAFLD patients
Level of parathyroid hormone level in NAFLD PATIENTS
Time frame: 1 year
Level of parathyroid hormone level in NAFLD PATIENTS and its relation to disease severity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Background: PubMed 26386476Sasso M, Audiere S, Kemgang A, Gaouar F, Corpechot C, Chazouilleres O, Fournier C, Golsztejn O, Prince S, Menu Y, Sandrin L, Miette V. Liver Steatosis Assessed by Controlled Attenuation Parameter (CAP) Measured with the XL Probe of the FibroScan: A Pilot Study Assessing Diagnostic Accuracy. Ultrasound Med Biol. 2016 Jan;42(1):92-103. doi: 10.1016/j.ultrasmedbio.2015.08.008. Epub 2015 Sep 19.
- Background: PubMed 26667191Ballestri S, Zona S, Targher G, Romagnoli D, Baldelli E, Nascimbeni F, Roverato A, Guaraldi G, Lonardo A. Nonalcoholic fatty liver disease is associated with an almost twofold increased risk of incident type 2 diabetes and metabolic syndrome. Evidence from a systematic review and meta-analysis. J Gastroenterol Hepatol. 2016 May;31(5):936-44. doi: 10.1111/jgh.13264.
- Results publication: PubMed 24042449Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.
- Results publication: PubMed 27973461Eshraghian A. Bone metabolism in non-alcoholic fatty liver disease: vitamin D status and bone mineral density. Minerva Endocrinol. 2017 Jun;42(2):164-172. doi: 10.23736/S0391-1977.16.02587-6. Epub 2016 Dec 14.
- Results publication: PubMed 28348479Poggiogalle E, Donini LM, Lenzi A, Chiesa C, Pacifico L. Non-alcoholic fatty liver disease connections with fat-free tissues: A focus on bone and skeletal muscle. World J Gastroenterol. 2017 Mar 14;23(10):1747-1757. doi: 10.3748/wjg.v23.i10.1747.
- Individual participant dataSharing planned: Undecided
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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.
Ghada Abdelrahman alkhateeb, Professor study director
Assiut University
Ahmed Mohammed mostafa ashmawy, Assistant professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and Osteoporosis, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mina Maged helmy habib, Reident of internal medecine (+201225760412, mon.maged@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of vit D level in serum in NAFLD patients (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT06038253, which also lists 5 linked publications.
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 15 Sep 2023.