Availability of Vitamin D in Orange Juice

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778114
• Other study ID #: H-26117
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: March 27, 2017
• Start date: December 2006
• Est. completion date: June 2007

Study information

• Verified date: March 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D2 in orange juice
1000 IU dose
• Vitamin D3 in orange juice
1000 IU
• Vitamin D2
capsule, 1000 IU
• Vitamin D3
capsule, 1000 IU

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. Erratum in: Am J Clin Nutr. 2003 Nov;78(5):1047. — View 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. Epub 2005 Mar 29. — View Citation

Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. Review. — View Citation

Holick MF. Sunlight "D"ilemma: risk of skin cancer or bone disease and muscle weakness. Lancet. 2001 Jan 6;357(9249):4-6. — View 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. — View Citation

Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare 25(OH)D levels in subjects taking vitamin D2 versus vitamin D3	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.	11 weeks
Other	Determine serum 1,25(OH)2D levels		11 weeks
Primary	Measurement of 25(OH)D levels after ingestion of 1,000 IU of vitamin D2 or vitamin D3 in a capsule		11 weeks
Secondary	Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice		11 weeks