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The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. The investigators hypothesis for these studies is that vitamin D supplementation enhances exercise-induced increases in strength and lean mass, potentially through enhancing insulin sensitivity and reducing inflammation.
The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. It was a double-blind, randomized, placebo-controlled, clinical trial with participants randomized into either a 4,000 IU/day vitamin D or placebo group and all participants completed 12 wks (3 d/wk) of exercise training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Participants in this arm consumed a 4000 IU vitamin D supplement daily for 12 weeks while participating in a resistance exercise training program. |
|
| Placebo | Placebo Comparator | Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 4000 IU of vitamin D per day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Function | The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention. | three months |
| Glucose Tolerance | The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention. | three months |
| Inflammation | The primary endpoint is the change in C reactive protein after the three month intervention | three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Teegarden, PhD | Purdue University | Principal Investigator |
| Michael G Flynn, PhD | College of Charleston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wastl Human Performance Laboratory, Purdue University | West Lafayette | Indiana | 47907 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23034474 | Derived | Carrillo AE, Flynn MG, Pinkston C, Markofski MM, Jiang Y, Donkin SS, Teegarden D. Impact of vitamin D supplementation during a resistance training intervention on body composition, muscle function, and glucose tolerance in overweight and obese adults. Clin Nutr. 2013 Jun;32(3):375-81. doi: 10.1016/j.clnu.2012.08.014. Epub 2012 Aug 31. |
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Following participant recruitment, baseline testing was completed prior to enrollment, study initiation and group assignment.
Recruitment Start Sept 2008 Recruitment at Purdue University
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program. |
| FG001 | Placebo | Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program. |
| BG001 | Placebo |
| 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 | Muscle Function | The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention. | Power statistical calculation was completed based on 80% power and error on lean mass measurement. | Posted | Mean | Standard Deviation | kilograms | three months |
|
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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 | Vitamin D | Were asked to consume 4000 IU of vitamin D/day for 3 months while performing a resistance training intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dorothy Teegarden | Purdue University | 765-494-8791 | teegarden@purdue.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo | Drug | Placebo (microcrystalline cellulose) ingestion each day for 12 weeks. |
|
|
Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Glucose Tolerance | The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention. | Power statistical calculation was completed based on 80% power and error on lean mass measurement. | Posted | Mean | Standard Deviation | mmol/L/120 min | three months |
|
|
|
| Primary | Inflammation | The primary endpoint is the change in C reactive protein after the three month intervention | Posted | Mean | Standard Deviation | mg/L | three months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Were asked to consume a placebo pill (microcrystalline cellulose) each day for 3 months while performing a resistance training intervention. | 0 | 0 | 0 | 0 |
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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 |
| D010335 | Pathologic Processes |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |