An interventional study of 1,000 IU vitamin D2 and placebo capsule in Vitamin D Deficiency, sponsored by USDA, Western Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-30.
Sponsored by USDA, Western Human Nutrition Research Center · Not applicable, Interventional, and Basic science
This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase their vitamin D2 content are actually a good source of vitamin D when consumed daily with a meal (lunch). The mushrooms will be provided cooked along with a meal which will be a standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in vitamin D status affects the immune system by decreasing it's level of activation, which may be abnormally elevated in vitamin D deficiency.
Volunteers will be asked to consume a standard meal (lunch) containing one serving of mushrooms daily for six weeks (7 days per week). With the meal, they will also need to take one capsule. The capsule will be either a placebo or will contain vitamin D. The purpose of the vitamin D in the capsule is to determine if the vitamin D from the mushrooms is absorbed as well as vitamin D from a capsule. The total dose of vitamin D that volunteers will receive each day from mushrooms and capsule together will always be the same and will be one of three doses: (1) little or no vitamin D (placebo); (2) 400 IU, which is near the current recommended intake and (3) 1,000 IU, which is up to five-fold higher than the current recommended intake, depending on your age. Both levels of vitamin D are safe. In addition to consuming the meals and taking the capsules, up to 20 mL (4 teaspoons) of blood will be drawn at three times during the study just before the mushroom-containing lunch is provided: (1) at the beginning of the study before the first meal; (3) after three weeks; (3) at the end of the study. The purpose of the blood draw is to measure vitamin D in your blood and to measure the level of activation of your immune system by measuring markers of immune activation.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 48 is below the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →USDA, Western Human Nutrition Research Center is the lead sponsor of 53 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Untreated mushrooms plus placebo capsule.
Dietary Supplement: placebo capsule · Other: mushrooms
UVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule.
Dietary Supplement: placebo capsule · Other: UVB-treated mushrooms, 400 IU vitamin D2
UVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule.
Dietary Supplement: placebo capsule · Other: UVB-treated mushrooms, 1,000 IU vitamin D2
Untreated mushrooms plus 1,000 IU Vitamin D2 in capsule
Dietary Supplement: 1,000 IU vitamin D2 · Other: mushrooms
capsule containing 1,000 IU vitamin D2
0 IU vitamin D2
untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA
UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA
UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA
Change in serum Vitamin D2
Serum vitamin D 2 will be measured in serum.
Time frame: 0, 3 and 6 weeks
Change in serum markers of inflammation
Measure serum cytokines, chemokines, and neopterin.
Time frame: 0, 3, and 6 weeks
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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USDA, Western Human Nutrition Research Center