NCT01815437

Brief Summary

This study will evaluate how much vitamin D is present in a mushroom supplement. This supplement contains an extract from mushrooms that have been exposed to sunlight. The mushroom supplement will be compared to non-commercially available vitamin D supplements produced in a Goo Manufacturing Practices (GMP)-licensed facility.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

February 2, 2012

Last Update Submit

March 23, 2017

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Changes in total 25(OH)D in mushroom supplement or crystalline supplement

    The primary outcome of this study is to examine changes in total 25(OH)D levels after ingestion of a vitamin D2 mushroom supplement manufactured by Monterey Mushrooms, Inc. compared to crystalline vitamin D2 from Nature's Life or vitamin D3 manufactured by Whole Health, Inc.

    12 weeks

Secondary Outcomes (1)

  • Changes in gene expression due to mushroom supplement or crystalline supplement

    12 weeks

Study Arms (4)

2000 IU Vitamin D3- Cholecalciferol

ACTIVE COMPARATOR

Take 2000 IU crystalline vitamin D3 once/day for 12 weeks.

Dietary Supplement: Cholecalciferol

2000 IU Vitamin D2- Ergocalciferol

ACTIVE COMPARATOR

Take 2000 IU crystalline vitamin D2 supplement once/day for 12 weeks.

Dietary Supplement: Vitamin D2 - Ergocalciferol

2000 IU Mushroom Vitamin D2

EXPERIMENTAL

Take 2000 IU vitamin D2 in a mushroom supplement once/day for 12 weeks

Dietary Supplement: Mushroom Vitamin D2

Mushroom Extract

PLACEBO COMPARATOR

Capsules with mushroom extract and no vitamin D. The intervention is mushroom extract.

Dietary Supplement: Mushroom Extract

Interventions

Mushroom Vitamin D2DIETARY_SUPPLEMENT

2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks

Also known as: Ergocalciferol
2000 IU Mushroom Vitamin D2
CholecalciferolDIETARY_SUPPLEMENT

2000 IU crystalline cholecalciferol once/day for 12 weeks

2000 IU Vitamin D3- Cholecalciferol
Vitamin D2 - ErgocalciferolDIETARY_SUPPLEMENT

2000 IU vitamin D2, ergocalciferol once/day for 12 weeks

Also known as: Ercocalciferol
2000 IU Vitamin D2- Ergocalciferol
Mushroom ExtractDIETARY_SUPPLEMENT

Same quantity of mushroom extract in a capsule

Mushroom Extract

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All healthy adults, male and female, age 18-64 years

You may not qualify if:

  • Currently taking, or having taken less than one month prior to start of study, a prescription of 50,000 IU of vitamin D2 or 2000 IU vitamin D2 or vitamin D3
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (9)

  • Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

    PMID: 17634462BACKGROUND

  • 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.

    PMID: 18524740BACKGROUND

  • 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.

    PMID: 19661054BACKGROUND

  • 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.

    PMID: 19064511BACKGROUND

  • 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.

    PMID: 16497887BACKGROUND

  • 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.

    PMID: 19237723BACKGROUND

  • 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.

    PMID: 18089691BACKGROUND

  • 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.

    PMID: 21118827BACKGROUND

  • 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.

    PMID: 19858440BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

ErgocalciferolsCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Michael F Holick, PhD, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2012

First Posted

March 21, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)