Availability of Vitamin D in Orange Juice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael F. Holick, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01778114
First received: January 23, 2013
Last updated: January 25, 2013
Last verified: January 2013

January 23, 2013
January 25, 2013
December 2006
June 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01778114 on ClinicalTrials.gov Archive Site
Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Same as current
  • Compare 25(OH)D levels in subjects taking vitamin D2 versus vitamin D3 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    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.
  • Determine serum 1,25(OH)2D levels [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Same as current
 
Availability of Vitamin D in Orange Juice
Bioavailability of Vitamin D2 and Vitamin D3 in Supplements Compared to Vitamin D3 and Vitamin D2 in Fortified Orange Juice

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Vitamin D Deficiency
  • Dietary Supplement: Vitamin D2 in orange juice
    1000 IU dose
  • Dietary Supplement: Vitamin D3 in orange juice
    1000 IU
  • Dietary Supplement: Vitamin D2
    capsule, 1000 IU
  • Dietary Supplement: Vitamin D3
    capsule, 1000 IU
  • Other: Placebo
    Placebo
  • Placebo Comparator: Placebo + orange juice without vitamin D
    Placebo + orange juice without vitamin D
    Intervention: Other: Placebo
  • Experimental: Placebo + 1000 IU vitamin D3 in OJ
    Vitamin D3 in orange juice
    Intervention: Dietary Supplement: Vitamin D3 in orange juice
  • Experimental: Placebo + 1000 IU vitamin D2 in OJ
    Vitamin D2 in orange juice
    Intervention: Dietary Supplement: Vitamin D2 in orange juice
  • Active Comparator: 1000 IU vitamin D3 + placebo OJ
    1000 IU vitamin D3 + placebo OJ
    Intervention: Dietary Supplement: Vitamin D3
  • Active Comparator: 1000 IU vitamin D2 + placebo OJ
    1000 IU vitamin D2 + placebo OJ
    Intervention: Dietary Supplement: Vitamin D2

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01778114
H-26117
No
Michael F. Holick, Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Michael F Holick, PhD, MD Boston University
Study Director: Rachael M Biancuzzo, BS, MA Boston University
Boston Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP