Vitamin D DeficiencyNCT02158143
A Single High-dose Oral Supplement of Vitamin D in Young Chinese
A study testing vitamin D3 in people with Vitamin D Deficiency, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Apr 2014
- Phase
- Interventional
- 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, younger, Chinese Hans aged from 25-35 years, including 25 and 35 years;
- haven't taken vitamin D supplement for the past 6 months;
- with a normal BMI (18-25 kg/m2);
- with baseline serum 25(OH)D < 30 ng/ml;
- be willing to follow the instruction and complete the study.
Who cannot join
- clinically diagnosed cardiovascular disease, gastrointestinal disease, endocrine, blood, liver, lung, kidney, nerve or mental illness;
- self-reported current use of any dietary supplements containing vitamin D within the 6 months before enrollment;
- Severe anemia (hemoglobin concentration < 70 g/L);
- Serum 25(OH)D ≥ 30 ng/mL at enrollment;
- participating in other research studies within the 3 months before enrollment;
- history of drug dependence or drug abuse;
Show all 9Show fewer
- History of heavy drinking (drinking 14 cups or more per week, equivalent to 360 mL beer or 150 mL white wine or 45 mL liquor per cup) and smokers (more than 10 cigarette per day);
- clinical abnormal of blood biochemistry, hematology or urine laboratory values;
- current pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute for Nutrition Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, 200031
About this study
evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D3
- 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.
vitamin D3Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 | Experimental | Not described Receives: Dietary Supplement: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of vitamin D3 supplementation on serum 25(OH)D changes
Measured: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum PTH
Measured: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum calcium
Measured: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum creatinine
Measured: within 140 day of supplementation
Effect of vitamin D3 supplementation on urinary calcium / creatinine
Measured: within 140 day after supplementation
Secondary outcomes (2)
Effect of vitamin D3 supplementation on fasting blood glucose
Measured: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum lipids
Measured: within 140 day after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hui Wang, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158143
- Sponsor's protocol ID
- CRC-KY1301
- Status last verified
- Jun 2014
- First submitted
- 5 Jun 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single High-dose Oral Supplement of Vitamin D in Young Chinese
- ClinicalTrials.gov ID
- NCT02158143
- Acronym / sponsor ID
- CRC-KY1301
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- First posted
- 6 Jun 2014 (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.
evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 | Experimental | Dietary Supplement: vitamin D3 |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, younger, Chinese Hans aged from 25-35 years, including 25 and 35 years;
- haven't taken vitamin D supplement for the past 6 months;
- with a normal BMI (18-25 kg/m2);
- with baseline serum 25(OH)D < 30 ng/ml;
- be willing to follow the instruction and complete the study.
Key exclusion criteria (9 listed)
- clinically diagnosed cardiovascular disease, gastrointestinal disease, endocrine, blood, liver, lung, kidney, nerve or mental illness;
- self-reported current use of any dietary supplements containing vitamin D within the 6 months before enrollment;
- Severe anemia (hemoglobin concentration < 70 g/L);
- Serum 25(OH)D ≥ 30 ng/mL at enrollment;
- participating in other research studies within the 3 months before enrollment;
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 |
|---|---|---|
| vitamin D3 | Dietary supplement | vitamin D3 |
Primary outcome
Effect of vitamin D3 supplementation on serum 25(OH)D changes
Time frame: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum PTH
Time frame: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum calcium
Time frame: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum creatinine
Time frame: within 140 day of supplementation
Effect of vitamin D3 supplementation on urinary calcium / creatinine
Time frame: within 140 day after supplementation
2 secondary outcomes
Effect of vitamin D3 supplementation on fasting blood glucose
Time frame: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum lipids
Time frame: within 140 day after supplementation
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 6 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 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 5 inclusion and 9 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 6 Jun 2014. 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?
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?
Effect of vitamin D3 supplementation on serum 25(OH)D changes (time frame: within 140 day after supplementation). The study lists 5 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 6 Jun 2014.