Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is, moved into the bloodstream. When the skin is exposed to sunlight during summer months, Vitamin D is made there and then modified into more active forms by the liver and kidneys. These more active forms of Vitamin D improve calcium absorption. Many adults living in the U.S. have little or no sun exposure and are low in Vitamin D. A single dose of 100,000 IU of Vitamin D3 has been used both as empiric treatment for Vitamin D deficiency as well as in controlled trials without risk of raising blood calcium to dangerous levels.This study is to determine the serum levels of Vitamin D and 25-hydroxyvitamin D (vitamin D after it has been modified by the liver) that can be expected when Vitamin D3 is given as a single oral dose of 100,000 IU.
The group receiving the supplement will be scheduled for short visits to our research center at baseline and days 1,3,5,7 and then weekly for 3 weeks and then every other week for 6 visits (total 14 visits in 4 months). The group not receiving supplement will be scheduled for short visits at baseline and in 4 months. At the beginning of the study we will measure your height, weight, skin color, and draw blood to measure your blood levels of Vitamin D, 25-hydroxyvitamin D, calcium and parathyroid hormone. At each visit we will draw blood to measure your blood levels of Vitamin D and 25-hydroxyvitamin D. There will be fourteen blood draws for a total of 280 cc of blood drawn (about 4 teaspoons drawn each time) in the supplemented group. There will be 2 blood draws in the group not receiving supplements for a total of 60 cc of blood drawn (about 4 teaspoons drawn each time).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cholecalciferol | Experimental | A single dose of 100,000 IU vitamin D |
|
| Control | No Intervention | No drug was given |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol. | Drug | 100,000 IU of Vitamin D |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| to assess the time course and response of serum 25-OHD with a single oral dose of 100,000 IU cholecalciferol. | 4 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura A Armas, MD | Creighton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University | Omaha | Nebraska | 68131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18326608 | Derived | Ilahi M, Armas LA, Heaney RP. Pharmacokinetics of a single, large dose of cholecalciferol. Am J Clin Nutr. 2008 Mar;87(3):688-91. doi: 10.1093/ajcn/87.3.688. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |