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Availability of Vitamin D in Orange Juice

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin D2 in orange juice

Vitamin D3 in orange juice

Vitamin D2

Vitamin D3

Placebo

About this trial

This is an interventional other trial for Vitamin D Deficiency focused on measuring Vitamin D2, Vitamin D3, Vitamin D, Orange Juice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female adults of all races ages 18 years and older

Exclusion Criteria:

Pregnant and lactating women
History of chronic severe liver (as defined by liver function test greater than 2 times upper limit of normal)or kidney disease as defined by a serum creatinine >2.5.
History of taking a daily supplement that contains 400 or more IU vitamin D2 or vitamin D3 within the past month or taking a pharmacologic amount of vitamin D2 or one of the active vitamin D analogs including Zemplar (Paricalcitol), Dovonex (calcipotriol), Hectorol (vitamin D pro hormone)
Subjects who are taking orally Dilantin or glucocorticoids.
Exposure to a tanning bed or tanning on a beach for more than eight hours within the past month.
Subjects who drink more than 2 glasses (16 oz) cups of milk a day.
Known history of elevated calcium. (> 10.5 mg% (mg/dl))
History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat malabsorption Syndrome, Crohn's Disease)
Allergies to orange juice
Any medical conditions in which it is not advisable to receive one 8 oz. glass of orange juice per day.
Currently taking, or having taken less than one month prior to start of study, a prescription vitamin D
Unwilling to consent to this trial

Sites / Locations

Boston University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo + orange juice without vitamin D

Placebo + 1000 IU vitamin D3 in OJ

Placebo + 1000 IU vitamin D2 in OJ

1000 IU vitamin D3 + placebo OJ

1000 IU vitamin D2 + placebo OJ

Arm Description

Placebo + orange juice without vitamin D

Vitamin D3 in orange juice

Vitamin D2 in orange juice

1000 IU vitamin D3 + placebo OJ

1000 IU vitamin D2 + placebo OJ

Outcomes

Primary Outcome Measures

Measurement of 25(OH)D levels after ingestion of 1,000 IU of vitamin D2 or vitamin D3 in a capsule

Secondary Outcome Measures

Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice

Full Information

NCT ID

NCT01778114

First Posted

January 23, 2013

Last Updated

March 27, 2017

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT01778114

Brief Title

Availability of Vitamin D in Orange Juice

Official Title

Bioavailability of Vitamin D2 and Vitamin D3 in Supplements Compared to Vitamin D3 and Vitamin D2 in Fortified Orange Juice

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study was to determine whether vitamin D2 and vitamin D3 in orange juice are effective at raising vitamin D levels in the blood and if vitamin D2 and vitamin D3 in orange juice raised blood levels of 25(OH)D as well as vitamin D3 and vitamin D2 supplements.

Detailed Description

This study should provide valuable information about the bioavailability of both vitamin D2 and vitamin D3 formulated in orange juice compared to vitamin D2 and vitamin D3 formulated in a pill and taken with water. It is anticipated based on our previous observation that the vitamin D2 and vitamin D3 in orange juice will be at least 50% more effective in raising the blood levels of 25(OH)D than when taken in pill form. This study will evaluate the bioavailability and metabolism of vitamin D2 and vitamin D3 in combination in tablet form. The results should provide important information as to whether a physiologic dose of vitamin D2 has a negative effect on circulating levels of 25-hydroxyvitamin D2 [25(OH)D2 ] and on 25-hydroxyvitamin D3 [25(OH)D3]. Results from this study have important implications for expanding the adequate intake (AI) recommendations for vitamin D2 and vitamin D3 for adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

Vitamin D2, Vitamin D3, Vitamin D, Orange Juice

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo + orange juice without vitamin D

Arm Type

Placebo Comparator

Arm Description

Placebo + orange juice without vitamin D

Arm Title

Placebo + 1000 IU vitamin D3 in OJ

Arm Type

Experimental

Arm Description

Vitamin D3 in orange juice

Arm Title

Placebo + 1000 IU vitamin D2 in OJ

Arm Type

Experimental

Arm Description

Vitamin D2 in orange juice

Arm Title

1000 IU vitamin D3 + placebo OJ

Arm Type

Active Comparator

Arm Description

1000 IU vitamin D3 + placebo OJ

Arm Title

1000 IU vitamin D2 + placebo OJ

Arm Type

Active Comparator

Arm Description

1000 IU vitamin D2 + placebo OJ

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D2 in orange juice

Intervention Description

1000 IU dose

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3 in orange juice

Intervention Description

1000 IU

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D2

Intervention Description

capsule, 1000 IU

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Intervention Description

capsule, 1000 IU

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Measurement of 25(OH)D levels after ingestion of 1,000 IU of vitamin D2 or vitamin D3 in a capsule

Time Frame

11 weeks

Secondary Outcome Measure Information:

Title

Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice

Time Frame

11 weeks

Other Pre-specified Outcome Measures:

Title

Compare 25(OH)D levels in subjects taking vitamin D2 versus vitamin D3

Description

It is debated in the literature that vitamin D2 is more effective than vitamin D3 in maintaining 25(OH)D levels in the blood. This outcome measure will help determine if this is true or if they are equally effective.

Time Frame

11 weeks

Title

Determine serum 1,25(OH)2D levels

Time Frame

11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female adults of all races ages 18 years and older Exclusion Criteria: Pregnant and lactating women History of chronic severe liver (as defined by liver function test greater than 2 times upper limit of normal)or kidney disease as defined by a serum creatinine >2.5. History of taking a daily supplement that contains 400 or more IU vitamin D2 or vitamin D3 within the past month or taking a pharmacologic amount of vitamin D2 or one of the active vitamin D analogs including Zemplar (Paricalcitol), Dovonex (calcipotriol), Hectorol (vitamin D pro hormone) Subjects who are taking orally Dilantin or glucocorticoids. Exposure to a tanning bed or tanning on a beach for more than eight hours within the past month. Subjects who drink more than 2 glasses (16 oz) cups of milk a day. Known history of elevated calcium. (> 10.5 mg% (mg/dl)) History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat malabsorption Syndrome, Crohn's Disease) Allergies to orange juice Any medical conditions in which it is not advisable to receive one 8 oz. glass of orange juice per day. Currently taking, or having taken less than one month prior to start of study, a prescription vitamin D Unwilling to consent to this trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael F Holick, PhD, MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rachael M Biancuzzo, BS, MA

Organizational Affiliation

Boston University

Official's Role

Study Director

Facility Information:

Facility Name

Boston University Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16529140

Citation

Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.

Results Reference

background

PubMed Identifier

11197362

Citation

Holick MF. Sunlight "D"ilemma: risk of skin cancer or bone disease and muscle weakness. Lancet. 2001 Jan 6;357(9249):4-6. doi: 10.1016/S0140-6736(00)03560-1. No abstract available.

Results Reference

background

PubMed Identifier

23115811

Citation

Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK109825/

Results Reference

background

PubMed Identifier

2839537

Citation

Webb AR, Kline L, Holick MF. Influence of season and latitude on the cutaneous synthesis of vitamin D3: exposure to winter sunlight in Boston and Edmonton will not promote vitamin D3 synthesis in human skin. J Clin Endocrinol Metab. 1988 Aug;67(2):373-8. doi: 10.1210/jcem-67-2-373.

Results Reference

background

PubMed Identifier

9519960

Citation

Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.

Results Reference

background

PubMed Identifier

12791627

Citation

Tangpricha V, Koutkia P, Rieke SM, Chen TC, Perez AA, Holick MF. Fortification of orange juice with vitamin D: a novel approach for enhancing vitamin D nutritional health. Am J Clin Nutr. 2003 Jun;77(6):1478-83. doi: 10.1093/ajcn/77.6.1478.

Results Reference

background

PubMed Identifier

15797954

Citation

Holick MF, Siris ES, Binkley N, Beard MK, Khan A, Katzer JT, Petruschke RA, Chen E, de Papp AE. Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab. 2005 Jun;90(6):3215-24. doi: 10.1210/jc.2004-2364. Epub 2005 Mar 29.

Results Reference

background

PubMed Identifier

12499343

Citation

Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. doi: 10.1093/ajcn/77.1.204. Erratum In: Am J Clin Nutr. 2003 Nov;78(5):1047.

Results Reference

background

PubMed Identifier

15531486

Citation

Armas LA, Hollis BW, Heaney RP. Vitamin D2 is much less effective than vitamin D3 in humans. J Clin Endocrinol Metab. 2004 Nov;89(11):5387-91. doi: 10.1210/jc.2004-0360.

Results Reference

background

PubMed Identifier

9771862

Citation

Trang HM, Cole DE, Rubin LA, Pierratos A, Siu S, Vieth R. Evidence that vitamin D3 increases serum 25-hydroxyvitamin D more efficiently than does vitamin D2. Am J Clin Nutr. 1998 Oct;68(4):854-8. doi: 10.1093/ajcn/68.4.854.

Results Reference

background

PubMed Identifier

20427729

Citation

Biancuzzo RM, Young A, Bibuld D, Cai MH, Winter MR, Klein EK, Ameri A, Reitz R, Salameh W, Chen TC, Holick MF. Fortification of orange juice with vitamin D(2) or vitamin D(3) is as effective as an oral supplement in maintaining vitamin D status in adults. Am J Clin Nutr. 2010 Jun;91(6):1621-6. doi: 10.3945/ajcn.2009.27972. Epub 2010 Apr 28.

Results Reference

result

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Availability of Vitamin D in Orange Juice

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