Vitamin D DeficiencyPhase 1NCT01817036
Vitamin D Intervention Trial in Healthy Chinese
A Phase 1 study testing Vitamin D in people with Vitamin D Deficiency, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
To determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L; Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jul 2013
- Phase
- Phase 1
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-45 years. with vitamin D deficiency (25(OH)D < 50 nmol/l)
Who cannot join
- BMI < 18.5 kg/m2, or BMI ≥ 25 kg/m2
- Total intake of calcium from diet or supplements >1200mg/d, or fasting serum calcium level ≥2.75 mmol/l
- Participating in other clinical studies within previous 3 months
- Taking vitamin D supplements within previous 3 months
- Using medications that may affect vitamin D metabolism in previous 3 months;
- Concomitant with clinical conditions, like liver dysfunction (serum alanine transaminase (ALT) ≥40 U/L; and/or aspartate transaminase (AST) ≥40 U/L; Glutamyl transpeptidase （GGT）≥50 U/L; serum creatinine < 50 or > 120 µmol/L; urea nitrogen (UN) < 7 or > 18 mg/dl, and/or urine acid <90 or >420 µmol/L; which may affect vitamin D metabolism;
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- History of drug or alcohol abuse (>40 g/d)
- Women during pregnancy or lactation
- Individuals with mental disorders or current use of antidepressants, the conditions which may affect him or her understanding and unwillingness to the intervention;
- Having clinically diagnosed AIDS, hepatitis A, hepatitis B, tuberculosis and other infectious diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Knowledge Innovation Project of CAS - Genetic and Nutritional Association Studies on Metabolism-related Diseases in Chinese Population -- Vitamin D Intervention Study：A Pilot Study
To determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L;
Read the detailed description
Recent epidemiological studies suggested that serum 25-hydroxyvitamin D [25(OH)D] concentration ≥75 nmol/L appeared to be optimal for preventing cardiometabolic diseases and improving bone health. To achieve this goal, a daily intake of 1000 IU or equivalent amount from other sources, is needed, which is twice as much as the RDA recommended by Chinese Nutrition Society. Meanwhile,epidemiological evidences show that large proportions of Chinese may suffer vitamin D insufficiency or deficiency whereas the current RDA in China might be too low to provide adequate vitamin D for people's health.
In order to fill up this gap, therefore, it is essential to determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L.Ultimately, the current study will provide important evidence for establishing optimal vitamin D requirement for Chinese people
- Conditions
- Vitamin D Deficiency
- Being tested
- Placebo, Vitamin D
- Keywords
- vitamin D, deficiency, dose response
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
placebo
Vitamin DDietary supplement
400 IU vitamin D per pill
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 5 placebo pills per day, 16 weeks Receives: Dietary Supplement: Placebo |
| 400 IU | Experimental | (4 placebo pills + 1 vitamin D pill) per day, 16 weeks Receives: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D |
| 800 IU | Experimental | (3 placebo pills + 2 vitamin D pills) per day, 16 weeks Receives: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D |
| 1200 IU | Experimental | (2 placebo pills + 3 vitamin D pills) per day, 16 weeks Receives: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D |
| 2000 IU | Experimental | 5 vitamin D pills per day, 16 weeks Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-hydroxyvitamin D
Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method
Measured: 16 weeks
Secondary outcomes (9)
alanine aminotransferase（ALT)
Serum ALT will be measured by an Automatic biochemical analyzer
Measured: 16 weeks
aspartate aminotransferase(AST)
Serum AST will be measured by an Automatic biochemical analyzer;
Measured: 16 weeks
glutamyl transpeptidase（GGT）
Serum GGT will be measured by an Automatic biochemical analyzer
Measured: 16 weeks
creatinine
creatinine will be measured by an Automatic biochemical analyzer
Measured: 16 weeks
uric acid
Serum uric acid will be measured by an Automatic biochemical analyzer
Measured: 16 weeks
urea nitrogen
Serum urea nitrogen will be measured by an Automatic biochemical analyzer
Measured: 16 weeks
calcium
Serum calcium will be measured by an Automatic biochemical analyzer.
Measured: 16 weeks
phosphate
Serum phosphate will be measured by an Automatic biochemical analyzer.
Measured: 16 weeks
parathyroid hormone（PTH）
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xu Lin, Chinese Academy of Sciences
- Investigators
- Xu Lin, PhD, Principal investigator, Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817036
- Sponsor's protocol ID
- KSCX2-EW-R-10-VD
- Status last verified
- Jan 2016
- First submitted
- 20 Mar 2013
- Last updated
- 18 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Innovation Project of CAS - Genetic and Nutritional Association Studies on Metabolism-related Diseases in Chinese Population -- Vitamin D Intervention Study：A Pilot Study
- ClinicalTrials.gov ID
- NCT01817036
- Acronym / sponsor ID
- KSCX2-EW-R-10-VD
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, deficiency, dose response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Mar 2013 (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.
To determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L;
Detailed description
Recent epidemiological studies suggested that serum 25-hydroxyvitamin D [25(OH)D] concentration ≥75 nmol/L appeared to be optimal for preventing cardiometabolic diseases and improving bone health. To achieve this goal, a daily intake of 1000 IU or equivalent amount from other sources, is needed, which is twice as much as the RDA recommended by Chinese Nutrition Society. Meanwhile,epidemiological evidences show that large proportions of Chinese may suffer vitamin D insufficiency or deficiency whereas the current RDA in China might be too low to provide adequate vitamin D for people's health.
In order to fill up this gap, therefore, it is essential to determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L.Ultimately, the current study will provide important evidence for establishing optimal vitamin D requirement for Chinese people
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo5 placebo pills per day, 16 weeks |
| 400 IU | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Vitamin D(4 placebo pills + 1 vitamin D pill) per day, 16 weeks |
| 800 IU | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Vitamin D(3 placebo pills + 2 vitamin D pills) per day, 16 weeks |
| 1200 IU | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Vitamin D(2 placebo pills + 3 vitamin D pills) per day, 16 weeks |
| 2000 IU | Experimental | Dietary Supplement: Vitamin D5 vitamin D pills per day, 16 weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age: 20-45 years. with vitamin D deficiency (25(OH)D < 50 nmol/l)
Key exclusion criteria (10 listed)
- BMI < 18.5 kg/m2, or BMI ≥ 25 kg/m2
- Total intake of calcium from diet or supplements >1200mg/d, or fasting serum calcium level ≥2.75 mmol/l
- Participating in other clinical studies within previous 3 months
- Taking vitamin D supplements within previous 3 months
- Using medications that may affect vitamin D metabolism in previous 3 months;
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 |
|---|---|---|
| Placeboplacebo | Dietary supplement | 1200 IU, 400 IU, 800 IU, Placebo |
| Vitamin D400 IU vitamin D per pill | Dietary supplement | 1200 IU, 2000 IU, 400 IU, 800 IU |
Primary outcome
25-hydroxyvitamin D
Time frame: 16 weeks
Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method
9 secondary outcomes
alanine aminotransferase（ALT)
Time frame: 16 weeks
aspartate aminotransferase(AST)
Time frame: 16 weeks
glutamyl transpeptidase（GGT）
Time frame: 16 weeks
creatinine
Time frame: 16 weeks
uric acid
Time frame: 16 weeks
urea nitrogen
Time frame: 16 weeks
calcium
Time frame: 16 weeks
phosphate
Time frame: 16 weeks
parathyroid hormone（PTH）
Time frame: 16 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 18 Jan 2016.
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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.
Xu Lin, PhD principal investigator
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D in people with Vitamin D Deficiency, run by Chinese Academy of Sciences 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 1 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: finished, as of the sponsor's last update on 18 Jan 2016. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
25-hydroxyvitamin D (time frame: 16 weeks). 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 18 Jan 2016.