Availability of Vitamin D in Orange Juice

NCT01778114 | Completed

• 1 other identifier: H-26117
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D2; Vitamin D3; Vitamin D; Orange Juice

Outcome Measures

Primary Outcomes (1)

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

  11 weeks

Secondary Outcomes (1)

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

  11 weeks

Other Outcomes (2)

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

  11 weeks

• Determine serum 1,25(OH)2D levels

  11 weeks

Study Arms (5)

Placebo + orange juice without vitamin D

PLACEBO COMPARATOR

Placebo + orange juice without vitamin D

Other: Placebo

Placebo + 1000 IU vitamin D3 in OJ

EXPERIMENTAL

Vitamin D3 in orange juice

Dietary Supplement: Vitamin D3 in orange juice

Placebo + 1000 IU vitamin D2 in OJ

EXPERIMENTAL

Vitamin D2 in orange juice

Dietary Supplement: Vitamin D2 in orange juice

1000 IU vitamin D3 + placebo OJ

ACTIVE COMPARATOR

1000 IU vitamin D3 + placebo OJ

Dietary Supplement: Vitamin D3

1000 IU vitamin D2 + placebo OJ

ACTIVE COMPARATOR

1000 IU vitamin D2 + placebo OJ

Dietary Supplement: Vitamin D2

Interventions

Vitamin D2 in orange juice DIETARY_SUPPLEMENT

1000 IU dose

Placebo + 1000 IU vitamin D2 in OJ

Vitamin D3 in orange juice DIETARY_SUPPLEMENT

1000 IU

Placebo + 1000 IU vitamin D3 in OJ

Vitamin D2 DIETARY_SUPPLEMENT

capsule, 1000 IU

1000 IU vitamin D2 + placebo OJ

Vitamin D3 DIETARY_SUPPLEMENT

capsule, 1000 IU

1000 IU vitamin D3 + placebo OJ

Placebo OTHER

Placebo

Placebo + orange juice without vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (11)

• 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.

  PMID: 16529140 BACKGROUND

• 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.

  PMID: 11197362 BACKGROUND

• 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/

  PMID: 23115811 BACKGROUND

• 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.

  PMID: 2839537 BACKGROUND

• 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.

  PMID: 9519960 BACKGROUND

• 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.

  PMID: 12791627 BACKGROUND

• 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.

  PMID: 15797954 BACKGROUND

• 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.

  PMID: 12499343 BACKGROUND

• 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.

  PMID: 15531486 BACKGROUND

• 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.

  PMID: 9771862 BACKGROUND

• 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.

  PMID: 20427729 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Michael F Holick, PhD, MD

  Boston University

  PRINCIPAL INVESTIGATOR

• Rachael M Biancuzzo, BS, MA

  Boston University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael . Holick PhD, MD

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 29, 2013
• Study Start: December 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)