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Completed

NCT Number: NCT01778114

Availability of Vitamin D in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D2 in orange juice

Dietary Supplement

1000 IU dose

Vitamin D3 in orange juice

Dietary Supplement

1000 IU

Vitamin D2

Dietary Supplement

capsule, 1000 IU

Vitamin D3

Dietary Supplement

capsule, 1000 IU

Placebo

Other

Placebo

Primary outcomes

  1. 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 outcomes

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

    Time frame: 11 weeks

Other outcomes

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

    Time frame: 11 weeks

    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.

  2. Determine serum 1,25(OH)2D levels

    Time frame: 11 weeks

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 29, 2013
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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