Fat Soluble Vitamin Deficiencies and DisordersNCT06512688
Establishing Reference Ranges for Fat-Soluble Vitamins in Healthy Chinese Adults
An observational study of Fat Soluble Vitamin Deficiencies and Disorders, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Vitamins are essential micronutrients required for maintaining normal physiological functions and metabolism in humans. Among them, fat-soluble vitamins (FSV) such as vitamins A, D, E, and K are absorbed in the intestines in the presence of fat. Both deficiencies and excesses of these vitamins can affect health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fat Soluble Vitamin Deficiencies and Disorders
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2024to 2 Aug 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18 and above who underwent physical examinations in collaborating hospitals from July 2024 to June 2026.
Who may be able to join
- Age ≥ 18 years old, both male and female;
- Undergo a health examination in this hospital and consciously maintain good physical health;
- Voluntarily participate in this study and sign an informed consent form;
- No acute and chronic diseases: no acute and chronic infections, cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, urinary diseases, thyroid diseases, digestive diseases, rheumatic diseases, blood system diseases, tumors, pituitary dysfunction; No hepatitis B, hepatitis C virus, or acquired immunodeficiency syndrome;
- Blood pressure: systolic blood pressure<140 mmHg and diastolic blood pressure<90 mmHg;
- BMI (body mass index):<28 kg/m2 and ≥ 18.5 kg/m2;
Show all 10Show fewer
- No surgery was performed within 6 months, no blood donation, transfusion, or significant blood loss occurred within 4 months;
- No long-term medication history, no medication or vitamin supplements taken within 2 weeks;
- Women who are not pregnant, breastfeeding, or within one year after childbirth;
- No alcohol abuse (alcohol consumption but alcohol intake<140 g/week for males and<70 g/week for females), and smoking (<20 cigarettes/day).
Who cannot join
- Serum alanine aminotransferase (ALT): Male>50 U/L, female>40 U/L; Or serum gamma glutamyltransferase (GGT): male>60 U/L, female>45 U/L; Or serum aspartate aminotransferase (AST): male>40 U/L, female>35 U/L; Or serum alkaline phosphatase (ALP): male>125 U/L, female (20-49 years old)>100 U/L, female (50-79 years old)>100 U/L;
- Serum albumin (ALB) < 40 g/L;
- Serum creatinine (SCr): Male (20-59 years old)>97 μ mol/L, male (60-79 years old)>111 μ mol/L; Female (20-59 years old)>73 μ mol/L, female (60-79 years old)>81 μ mol/L;
- Fasting blood glucose (FBG) ≥ 7.0 mmol/L;
- White blood cell count (WBC): < 3.5 × 109/L or > 9.5 × 109/L;
- Hemoglobin (Hb): Male < 120 g/L; Female<110 g/L;
Show all 10Show fewer
- Glycated hemoglobin (HbA1c)<4% or>6%;
- Total cholesterol (TC) ≥ 5.2 mmol/L; Or triglycerides (TG) ≥ 1.7 mmol/L;
- Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L; Or high-density lipoprotein cholesterol (HDL-C)<1.0 mmol/L;
- Serum uric acid (UA)>420 μ mol/L.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Zhong Liu, +86 13957104885, liuzhongzheyi@zju.edu.cn
About this study
Vitamins are essential micronutrients required for maintaining normal physiological functions and metabolism in humans. Among them, fat-soluble vitamins (FSV) such as vitamins A, D, E, and K are absorbed in the intestines in the presence of fat. Both deficiencies and excesses of these vitamins can affect health. Current global studies on FSVs in healthy populations are often limited to specific types or regions, and comprehensive data on all four FSVs in the healthy Chinese population are lacking. This study aims to fill this gap by collecting and analyzing FSV levels from healthy adults across multiple regions in China, establishing a reference range for clinical evaluation and early disease intervention.
Read the detailed description
Vitamins are crucial organic micronutrients necessary for maintaining human physiological functions and metabolic processes. They are typically categorized into water-soluble vitamins and fat-soluble vitamins (FSVs). The primary FSVs include vitamins A, D, E, and K, which are absorbed in the intestines in the presence of dietary fat.
The balance of these vitamins in the body is vital for health. Deficiencies or excesses can lead to significant health issues. For example, a deficiency in vitamin A can cause night blindness, a lack of vitamin D can lead to osteomalacia, insufficient vitamin E can result in increased oxidative stress in cells, and a deficiency in vitamin K can cause bleeding disorders.
Globally, research on FSVs in healthy populations is usually focused on specific vitamins or limited to particular regions and demographics. Consequently, there is a scarcity of comprehensive data on the concentration of all four FSVs at the population level. In China, there has been no extensive study that simultaneously analyzes the levels of all four FSVs in a healthy adult population.
This study addresses this gap through a multicenter approach, collecting data on the levels of vitamins A, D, E, and K from healthy adults across various regions in China. The goal is to establish a reference range for serum FSV levels in Chinese adults. This database will serve as a scientific foundation for accurately assessing FSV levels in clinical settings and providing early intervention for diseases related to FSV imbalances. Additionally, this research aims to enhance understanding of the nutritional status of the Chinese population and guide dietary recommendations and public health policies to improve overall health outcomes.
- Keywords
- Reference Interval, Healthy Chinese Adults
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
This is a cross-sectional study without intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
serum vitamin A
Measured: day 1
serum vitamin D
Measured: day 1
serum vitamin E
Measured: day 1
serum vitamin K
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start3 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion2 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat Soluble Vitamin Deficiencies and DisordersStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Huizhou Municipal Central Hospital, Affiliated Hospital of Jiaxing University, Zhejiang Provincial Tongde Hospital, Affiliated Yueqing Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Zhejiang Provincial People's Hospital, First People's Hospital of Hangzhou, Ningbo Medical Center Lihuili Hospital, Lu'an People's Hospital of Anhui Province, Shandong Provincial Hospital, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Nanchang University, Nanfang Hospital, Southern Medical University, The Third Xiangya Hospital of Central South University, Changzhi Medical College, Linfen No.4 People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, Yulin No.2 Hospital, Hanzhong Central Hospital
- Responsible party
- Principal investigator, Liu Zhong, First Affiliated Hospital of Zhejiang University
- Investigators
- Zhong Liu, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512688
- Sponsor's protocol ID
- 20240364
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Reference Ranges for Fat-Soluble Vitamins in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT06512688
- Acronym / sponsor ID
- 20240364
- Keywords
- Reference Interval, Healthy Chinese Adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Huizhou Municipal Central Hospital, Affiliated Hospital of Jiaxing University, Zhejiang Provincial Tongde Hospital, Affiliated Yueqing Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Zhejiang Provincial People's Hospital, First People's Hospital of Hangzhou, Ningbo Medical Center Lihuili Hospital, Lu'an People's Hospital of Anhui Province, Shandong Provincial Hospital, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Nanchang University, Nanfang Hospital, Southern Medical University, The Third Xiangya Hospital of Central South University, Changzhi Medical College, Linfen No.4 People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, Yulin No.2 Hospital, Hanzhong Central Hospital
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 2 Aug 2026 (estimated)
- First posted
- 22 Jul 2024 (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.
Vitamins are essential micronutrients required for maintaining normal physiological functions and metabolism in humans. Among them, fat-soluble vitamins (FSV) such as vitamins A, D, E, and K are absorbed in the intestines in the presence of fat. Both deficiencies and excesses of these vitamins can affect health. Current global studies on FSVs in healthy populations are often limited to specific types or regions, and comprehensive data on all four FSVs in the healthy Chinese population are lacking. This study aims to fill this gap by collecting and analyzing FSV levels from healthy adults across multiple regions in China, establishing a reference range for clinical evaluation and early disease intervention.
Detailed description
Vitamins are crucial organic micronutrients necessary for maintaining human physiological functions and metabolic processes. They are typically categorized into water-soluble vitamins and fat-soluble vitamins (FSVs). The primary FSVs include vitamins A, D, E, and K, which are absorbed in the intestines in the presence of dietary fat.
The balance of these vitamins in the body is vital for health. Deficiencies or excesses can lead to significant health issues. For example, a deficiency in vitamin A can cause night blindness, a lack of vitamin D can lead to osteomalacia, insufficient vitamin E can result in increased oxidative stress in cells, and a deficiency in vitamin K can cause bleeding disorders.
Globally, research on FSVs in healthy populations is usually focused on specific vitamins or limited to particular regions and demographics. Consequently, there is a scarcity of comprehensive data on the concentration of all four FSVs at the population level. In China, there has been no extensive study that simultaneously analyzes the levels of all four FSVs in a healthy adult population.
This study addresses this gap through a multicenter approach, collecting data on the levels of vitamins A, D, E, and K from healthy adults across various regions in China. The goal is to establish a reference range for serum FSV levels in Chinese adults. This database will serve as a scientific foundation for accurately assessing FSV levels in clinical settings and providing early intervention for diseases related to FSV imbalances. Additionally, this research aims to enhance understanding of the nutritional status of the Chinese population and guide dietary recommendations and public health policies to improve overall health outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 and above who underwent physical examinations in collaborating hospitals from July 2024 to June 2026.
Key inclusion criteria (10 listed)
- Age ≥ 18 years old, both male and female;
- Undergo a health examination in this hospital and consciously maintain good physical health;
- Voluntarily participate in this study and sign an informed consent form;
- No acute and chronic diseases: no acute and chronic infections, cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, urinary diseases, thyroid diseases, digestive diseases, rheumatic diseases, blood system diseases, tumors, pituitary dysfunction; No hepatitis B, hepatitis C virus, or acquired immunodeficiency syndrome;
- Blood pressure: systolic blood pressure<140 mmHg and diastolic blood pressure<90 mmHg;
Key exclusion criteria (10 listed)
- Serum alanine aminotransferase (ALT): Male>50 U/L, female>40 U/L; Or serum gamma glutamyltransferase (GGT): male>60 U/L, female>45 U/L; Or serum aspartate aminotransferase (AST): male>40 U/L, female>35 U/L; Or serum alkaline phosphatase (ALP): male>125 U/L, female (20-49 years old)>100 U/L, female (50-79 years old)>100 U/L;
- Serum albumin (ALB) < 40 g/L;
- Serum creatinine (SCr): Male (20-59 years old)>97 μ mol/L, male (60-79 years old)>111 μ mol/L; Female (20-59 years old)>73 μ mol/L, female (60-79 years old)>81 μ mol/L;
- Fasting blood glucose (FBG) ≥ 7.0 mmol/L;
- White blood cell count (WBC): < 3.5 × 109/L or > 9.5 × 109/L;
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 |
|---|---|---|
| This is a cross-sectional study without intervention. | Other | – |
Primary outcome
serum vitamin A
Time frame: day 1
serum vitamin D
Time frame: day 1
serum vitamin E
Time frame: day 1
serum vitamin K
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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.
Zhong Liu principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fat Soluble Vitamin Deficiencies and Disorders, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Liu (+86 13957104885, liuzhongzheyi@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum vitamin A (time frame: day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2024.