Availability of Vitamin D in Orange Juice

March 27, 2017 updated by: Michael F. Holick, Boston University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo + orange juice without vitamin D
Other: Placebo
Placebo
Experimental: Placebo + 1000 IU vitamin D3 in OJ
Vitamin D3 in orange juice
Dietary supplement: Vitamin D3 in orange juice
1000 IU
Experimental: Placebo + 1000 IU vitamin D2 in OJ
Vitamin D2 in orange juice
Dietary supplement: Vitamin D2 in orange juice
1000 IU dose
Active Comparator: 1000 IU vitamin D3 + placebo OJ
Dietary supplement: Vitamin D3
capsule, 1000 IU
Active Comparator: 1000 IU vitamin D2 + placebo OJ
Dietary supplement: Vitamin D2
capsule, 1000 IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
11 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice
Time Frame: 11 weeks
11 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
11 weeks
Determine serum 1,25(OH)2D levels
Time Frame: 11 weeks
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Investigators

  • Principal Investigator: Michael F Holick, PhD, MD, Boston University
  • Study Director: Rachael M Biancuzzo, BS, MA, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-26117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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