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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD057126-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Purdue University | OTHER |
| Indiana University | OTHER |
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While a large percentage of children have low blood vitamin D levels, the significance of these low levels and the impact on health is unclear. The purpose of this project is to determine the effects of varying doses of vitamin D supplementation over 12 weeks on blood indicators of health in white and black children, aged 9 to 13 years, from both the northern and southern US.
Vitamin D intakes in children do not meet current US Dietary Reference Intake recommendations and emerging evidence suggests that a significant number of children, particularly those with darker skin pigmentation, have inadequate levels of serum 25-hydroxyvitamin D [25(OH)D]. The optimum level of circulating 25(OH)D has not been clearly defined in children, nor is it known what functional outcome measures are ideal for defining this level, or if these requirements would differ by race. Graded doses of vitamin D3 supplementation will be used in this dual-site, 12-week trial. The investigators hypothesize that a dose-response relationship will be observed between vitamin D supplementation and intermediate endpoints of skeletal health, and that race will modify these responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo tablet |
|
| 400 IU | Experimental | Vitamin D3 tablet, 400 IU |
|
| 1,000 IU | Experimental | Vitamin D3 tablet, 1,000 IU |
|
| 2,000 IU | Experimental | Vitamin D3 tablet, 2,000 IU |
|
| 4,000 IU | Experimental | Vitamin D3 tablet, 4,000 IU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum 25(OH)D | 0 weeks | |
| PTH | 0 weeks | |
| 1,25(OH)2D | 0 weeks | |
| fractional calcium absorption | 0 weeks | |
| biochemical markers of bone turnover | 0 weeks | |
| serum 25(OH)D | 3 weeks | |
| serum 25(OH)D | 6 weeks | |
| serum 25(OH)D | 9 weeks | |
| serum 25(OH)D | 12 weeks | |
| PTH | 3 weeks | |
| PTH | 6 weeks | |
| PTH | 9 weeks | |
| PTH | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| sunlight exposure | 0 weeks | |
| dietary data | 0 weeks | |
| physical activity data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Lewis, PhD | The University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Georgia Dept of Foods & Nutrition | Athens | Georgia | 30602 | United States | ||
| Indiana University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24092833 | Result | Lewis RD, Laing EM, Hill Gallant KM, Hall DB, McCabe GP, Hausman DB, Martin BR, Warden SJ, Peacock M, Weaver CM. A randomized trial of vitamin D(3) supplementation in children: dose-response effects on vitamin D metabolites and calcium absorption. J Clin Endocrinol Metab. 2013 Dec;98(12):4816-25. doi: 10.1210/jc.2013-2728. Epub 2013 Oct 3. | |
| 30001469 | Derived | Wright CS, Laing EM, Pollock NK, Hausman DB, Weaver CM, Martin BR, McCabe GP, Peacock M, Warden SJ, Hill Gallant KM, Lewis RD. Serum 25-Hydroxyvitamin D and Intact Parathyroid Hormone Influence Muscle Outcomes in Children and Adolescents. J Bone Miner Res. 2018 Nov;33(11):1940-1947. doi: 10.1002/jbmr.3550. Epub 2018 Aug 27. |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 1,25(OH)2D | 3 weeks |
| 1,25(OH)2D | 6 weeks |
| 1,25(OH)2D | 9 weeks |
| 1,25(OH)2D | 12 weeks |
| fractional calcium absorption | 12 weeks |
| biochemical markers of bone turnover | 3 weeks |
| biochemical markers of bone turnover | 6 weeks |
| biochemical markers of bone turnover | 9 weeks |
| biochemical markers of bone turnover | 12 weeks |
| 0 weeks |
| serum and urinary calcium | 0 weeks |
| body composition | 0 weeks |
| sunlight exposure | 3 weeks |
| sunlight exposure | 6 weeks |
| sunlight exposure | 9 weeks |
| sunlight exposure | 12 weeks |
| dietary data | 3 weeks |
| dietary data | 6 weeks |
| dietary data | 9 weeks |
| dietary data | 12 weeks |
| physical activity data | 3 weeks |
| physical activity data | 6 weeks |
| physical activity data | 9 weeks |
| physical activity data | 12 weeks |
| serum and urinary calcium | 3 weeks |
| serum and urinary calcium | 6 weeks |
| serum and urinary calcium | 9 weeks |
| serum and urinary calcium | 12 weeks |
| body composition | 3 weeks |
| body composition | 6 weeks |
| body composition | 9 weeks |
| body composition | 12 weeks |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Purdue University | West Lafayette | Indiana | 47907 | United States |
| 28286536 | Derived | Giudici KV, Kindler JM, Martin BR, Laing EM, McCabe GP, McCabe LD, Hausman DB, Martini LA, Lewis RD, Weaver CM, Peacock M, Hill Gallant KM. Associations among osteocalcin, leptin and metabolic health in children ages 9-13 years in the United States. Nutr Metab (Lond). 2017 Mar 7;14:25. doi: 10.1186/s12986-017-0171-9. eCollection 2017. |
| 26885880 | Derived | Ferira AJ, Laing EM, Hausman DB, Hall DB, McCabe GP, Martin BR, Hill Gallant KM, Warden SJ, Weaver CM, Peacock M, Lewis RD. Vitamin D Supplementation Does Not Impact Insulin Resistance in Black and White Children. J Clin Endocrinol Metab. 2016 Apr;101(4):1710-8. doi: 10.1210/jc.2015-3687. Epub 2016 Feb 17. |
| 22750015 | Derived | Hill KM, Laing EM, Hausman DB, Acton A, Martin BR, McCabe GP, Weaver CM, Lewis RD, Peacock M. Bone turnover is not influenced by serum 25-hydroxyvitamin D in pubertal healthy black and white children. Bone. 2012 Oct;51(4):795-9. doi: 10.1016/j.bone.2012.06.014. Epub 2012 Jun 28. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |