Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2012-01-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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2000 IU Vitamin D3- Cholecalciferol
Take 2000 IU crystalline vitamin D3 once/day for 12 weeks.
Cholecalciferol
2000 IU crystalline cholecalciferol once/day for 12 weeks
2000 IU Vitamin D2- Ergocalciferol
Take 2000 IU crystalline vitamin D2 supplement once/day for 12 weeks.
Vitamin D2 - Ergocalciferol
2000 IU vitamin D2, ergocalciferol once/day for 12 weeks
2000 IU Mushroom Vitamin D2
Take 2000 IU vitamin D2 in a mushroom supplement once/day for 12 weeks
Mushroom Vitamin D2
2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks
Mushroom Extract
Capsules with mushroom extract and no vitamin D. The intervention is mushroom extract.
Mushroom Extract
Same quantity of mushroom extract in a capsule
Interventions
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Mushroom Vitamin D2
2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks
Cholecalciferol
2000 IU crystalline cholecalciferol once/day for 12 weeks
Vitamin D2 - Ergocalciferol
2000 IU vitamin D2, ergocalciferol once/day for 12 weeks
Mushroom Extract
Same quantity of mushroom extract in a capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergy to mushrooms
* History of elevated calcium (\>10.4 mg%)
* Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
* Supplementation with over the counter formulations of vitamin D2 or vitamin D3
* Subjects with a history of an adverse reaction to orally administered vitamin D.
* Subjects who are taking oral Dilantin or glucocorticoids.
* Exposure to a tanning bed or tanning on a beach for more than eight hours with no sunscreen within 2 weeks prior to start of study.
* History of intestinal malabsorption (i.e. cystic fibrosis, fat malabsorption syndrome, Crohn's Disease, gastric bypass surgery).
* Subjects with any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
18 Years
64 Years
ALL
Yes
Sponsors
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Boston University
OTHER
Responsible Party
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Principal Investigators
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Michael F Holick, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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References
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Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Rovner AJ, O'Brien KO. Hypovitaminosis D among healthy children in the United States: a review of the current evidence. Arch Pediatr Adolesc Med. 2008 Jun;162(6):513-9. doi: 10.1001/archpedi.162.6.513.
Kumar J, Muntner P, Kaskel FJ, Hailpern SM, Melamed ML. Prevalence and associations of 25-hydroxyvitamin D deficiency in US children: NHANES 2001-2004. Pediatrics. 2009 Sep;124(3):e362-70. doi: 10.1542/peds.2009-0051. Epub 2009 Aug 3.
Looker AC, Pfeiffer CM, Lacher DA, Schleicher RL, Picciano MF, Yetley EA. Serum 25-hydroxyvitamin D status of the US population: 1988-1994 compared with 2000-2004. Am J Clin Nutr. 2008 Dec;88(6):1519-27. doi: 10.3945/ajcn.2008.26182.
Liu PT, Stenger S, Li H, Wenzel L, Tan BH, Krutzik SR, Ochoa MT, Schauber J, Wu K, Meinken C, Kamen DL, Wagner M, Bals R, Steinmeyer A, Zugel U, Gallo RL, Eisenberg D, Hewison M, Hollis BW, Adams JS, Bloom BR, Modlin RL. Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response. Science. 2006 Mar 24;311(5768):1770-3. doi: 10.1126/science.1123933. Epub 2006 Feb 23.
Ginde AA, Mansbach JM, Camargo CA Jr. Association between serum 25-hydroxyvitamin D level and upper respiratory tract infection in the Third National Health and Nutrition Examination Survey. Arch Intern Med. 2009 Feb 23;169(4):384-90. doi: 10.1001/archinternmed.2008.560.
Holick MF, Biancuzzo RM, Chen TC, Klein EK, Young A, Bibuld D, Reitz R, Salameh W, Ameri A, Tannenbaum AD. Vitamin D2 is as effective as vitamin D3 in maintaining circulating concentrations of 25-hydroxyvitamin D. J Clin Endocrinol Metab. 2008 Mar;93(3):677-81. doi: 10.1210/jc.2007-2308. Epub 2007 Dec 18.
Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.
Pietras SM, Obayan BK, Cai MH, Holick MF. Vitamin D2 treatment for vitamin D deficiency and insufficiency for up to 6 years. Arch Intern Med. 2009 Oct 26;169(19):1806-8. doi: 10.1001/archinternmed.2009.361. No abstract available.
Other Identifiers
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MU100
Identifier Type: -
Identifier Source: org_study_id
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