ObesityNCT01781169
Vitamin D Supplementation to Obese Chinese Males
A study testing Oral supplementation of vitamin D in people with Obesity and Insulin Resistance, run by Shenzhen Center for Chronic Disease Control at 1 site in China.
Trial summary
Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males. Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Read more about this study
- Who is it for?
- Ages 23 to 66 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Oral supplementation of vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 23 to 66 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- body mass index (BMI) ≥ 28kg/m2 or 18.5 ≤ BMI < 24 (kg/m2)
- non vegetarian Han Chinese and did not smoke, drink, nor take vitamin D supplements for > 2 y
- fasting serum glucose < 7.0 mmol/L
- serum glucose of 2 hr after 75 g oral glucose loading < 11.1 mmol/L
- normal functioning of liver and kidney evaluated by alkaline phosphatase, aspartate aminotransferase, creatinine, and uric acid
Who cannot join
- not match the above inclusion criteria
- diagnosed as having any organic diseases were excluded
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Center for Chronic Disease Control
Shenzhen, Guangdong, 518020
About this study
Official title: Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males
Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males.
Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Oral supplementation of vitamin D
- Keywords
- Vitamin D,, Oral supplementation,, Obese males
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral supplementation of vitamin DDietary supplement
Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males. The chemical form of vitamin D is cholecalciferol capsuled as fine powder.
| Study group | Role | What they receive |
|---|---|---|
| Obese group | Experimental | Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. Receives: Dietary Supplement: Oral supplementation of vitamin D |
| Normal-weight group | Experimental | Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. Receives: Dietary Supplement: Oral supplementation of vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)
Measured: Endpoint and baseline of the 8 weeks' trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Center for Chronic Disease Control
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Institute China Diet Nutrition Research and Communication
- Responsible party
- Principal investigator, Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
- Investigators
- Ji-Chang Zhou, Ph.D, Principal investigator, Shenzhen Center for Chronic Disease Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781169
- Sponsor's protocol ID
- VD50kIU2011
- Status last verified
- Sep 2013
- First submitted
- 25 Jan 2013
- Last updated
- 30 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.
PubMed 21177785Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.
PubMed 9519960Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
PubMed 17634462
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effect of Oral Vitamin D Supplementation on Obese Chinese Males
- ClinicalTrials.gov ID
- NCT01781169
- Acronym / sponsor ID
- VD50kIU2011
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Vitamin D,, Oral supplementation,, Obese males
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Shenzhen Center for Chronic Disease ControlUniversity, hospital or other
- Collaborators
- Danone Institute China Diet Nutrition Research and Communication
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 30 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males.
Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese group | Experimental | Dietary Supplement: Oral supplementation of vitamin DOral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. |
| Normal-weight group | Experimental | Dietary Supplement: Oral supplementation of vitamin DOral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. |
Who may qualify
- Ages
- 23 to 66 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- body mass index (BMI) ≥ 28kg/m2 or 18.5 ≤ BMI < 24 (kg/m2)
- non vegetarian Han Chinese and did not smoke, drink, nor take vitamin D supplements for > 2 y
- fasting serum glucose < 7.0 mmol/L
- serum glucose of 2 hr after 75 g oral glucose loading < 11.1 mmol/L
- normal functioning of liver and kidney evaluated by alkaline phosphatase, aspartate aminotransferase, creatinine, and uric acid
Key exclusion criteria (2 listed)
- not match the above inclusion criteria
- diagnosed as having any organic diseases were excluded
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 |
|---|---|---|
| Oral supplementation of vitamin DWeekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males. The chemical form of vitamin D is cholecalciferol capsuled as fine powder. | Dietary supplement | Normal-weight group, Obese group |
Primary outcome
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)
Time frame: Endpoint and baseline of the 8 weeks' trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21177785Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. J Clin Endocrinol Metab. 2011 Mar;96(3):E447-52. doi: 10.1210/jc.2010-2230. Epub 2010 Dec 22.
- Results publication: PubMed 9519960Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.
- Results publication: PubMed 17634462Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
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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.
Ji-Chang Zhou, Ph.D principal investigator
Shenzhen Center for Chronic Disease Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral supplementation of vitamin D in people with Obesity and Insulin Resistance, run by Shenzhen Center for Chronic Disease Control 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 2 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 30 Oct 2013. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) (time frame: Endpoint and baseline of the 8 weeks' trial). 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 NCT01781169, which also lists 3 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 30 Oct 2013.