Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 3R01HL106160 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Office of Dietary Supplements (ODS) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Boston University | OTHER |
| Boston Children's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.
Research suggests that vitamin D, known mainly for its role in bone health, may have other roles in the body and that vitamin D deficiency may contribute to certain chronic diseases, such as cardiovascular disease. Recently, vitamin D has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin D deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D intakes should be increased to 600 IU/day for children ages 1-18. However, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL. Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are Latino or African American; and 2) whether serum concentrations of 25(OH)D over 30 ng/mL in children prevent health risks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D3 600 IU/ daily | Active Comparator | Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months. |
|
| D3 1000 IU/ daily | Active Comparator | Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months. |
|
| D3: 2000 IU/daily | Active Comparator | Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | Subjects are told to take vitamin D daily for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vitamin D levels over six month period | Subjects will be randomized to receive one of three doses of vitamin D3. Baseline serum 25(OH)D levels will be compared to serum 25(OH)D at 3 and 6 months. Safety Issue?: (FDAAA) No | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status | Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Sacheck, PhD | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21784451 | Background | Sacheck J, Goodman E, Chui K, Chomitz V, Must A, Economos C. Vitamin D deficiency, adiposity, and cardiometabolic risk in urban schoolchildren. J Pediatr. 2011 Dec;159(6):945-50. doi: 10.1016/j.jpeds.2011.06.001. Epub 2011 Jul 23. | |
| 34550329 | Derived | Sacheck JM, Huang Q, Van Rompay MI, Chomitz VR, Economos CD, Eliasziw M, Gordon CM, Goodman E. Vitamin D supplementation and cardiometabolic risk factors among diverse schoolchildren: a randomized clinical trial. Am J Clin Nutr. 2022 Jan 11;115(1):73-82. doi: 10.1093/ajcn/nqab319. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Vitamin D3 | Dietary Supplement | Subjects are asked to take vitamin D orally, daily for six months. |
|
| 29394922 | Derived | Blakeley CE, Van Rompay MI, Schultz NS, Sacheck JM. Relationship between muscle strength and dyslipidemia, serum 25(OH)D, and weight status among diverse schoolchildren: a cross-sectional analysis. BMC Pediatr. 2018 Feb 2;18(1):23. doi: 10.1186/s12887-018-0998-x. |
| 29029097 | Derived | Sacheck JM, Van Rompay MI, Chomitz VR, Economos CD, Eliasziw M, Goodman E, Gordon CM, Holick MF. Impact of Three Doses of Vitamin D3 on Serum 25(OH)D Deficiency and Insufficiency in At-Risk Schoolchildren. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4496-4505. doi: 10.1210/jc.2017-01179. |
| 26936138 | Derived | Sawicki CM, Van Rompay MI, Au LE, Gordon CM, Sacheck JM. Sun-Exposed Skin Color Is Associated with Changes in Serum 25-Hydroxyvitamin D in Racially/Ethnically Diverse Children. J Nutr. 2016 Apr;146(4):751-7. doi: 10.3945/jn.115.222505. Epub 2016 Mar 2. |
| 26338888 | Derived | Van Rompay MI, McKeown NM, Goodman E, Eliasziw M, Chomitz VR, Gordon CM, Economos CD, Sacheck JM. Sugar-Sweetened Beverage Intake Is Positively Associated with Baseline Triglyceride Concentrations, and Changes in Intake Are Inversely Associated with Changes in HDL Cholesterol over 12 Months in a Multi-Ethnic Sample of Children. J Nutr. 2015 Oct;145(10):2389-95. doi: 10.3945/jn.115.212662. Epub 2015 Sep 2. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |