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| Name | Class |
|---|---|
| Danone Institute China Diet Nutrition Research and Communication | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese group | Experimental | Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. |
|
| Normal-weight group | Experimental | Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral supplementation of vitamin D | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) | Endpoint and baseline of the 8 weeks' trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji-Chang Zhou, Ph.D | Shenzhen Center for Chronic Disease Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Center for Chronic Disease Control | Shenzhen | Guangdong | 518020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21177785 | Background | 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. | |
| 9519960 | Result | Malabanan 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. |
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After enrollment, baseline information of the volunteers including vitamin D nutritional status, health records, etc. were evaluated. Including and excluding criteria were used to select the subjects who were suitable for the intervention trial.
Subjects were recruited at a medical clinic (Health Service Center of Shuiku Community, Shenzhen, China) in May, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Obese Group | Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. |
| FG001 | Normal-weight Group | Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal-weight Group | |
| BG001 | Obese Group | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L) | Posted | Mean | Standard Deviation | nmol/L | Endpoint and baseline of the 8 weeks' trial |
|
|
Eight weeks of the trial for all the participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal-weight Group |
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The numbers of participants in both the obese group and normal-weight group were small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ji-Chang Zhou | Shenzhen Center for Chronic Disease Control | 86-755-25503842 | jichangzhou@gmail.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 17634462 | Result | Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available. |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Obese Group | 0 | 22 | 0 | 22 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |