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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
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Dietary Supplement: Vitamin D2 in orange juice
Dietary Supplement: Vitamin D3 in orange juice
Dietary Supplement: Vitamin D2
Dietary Supplement: Vitamin D3
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Bioavailability of Vitamin D2 and Vitamin D3 in Supplements Compared to Vitamin D3 and Vitamin D2 in Fortified Orange Juice

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ]

Enrollment: 86
Study Start Date: December 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + orange juice without vitamin D
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
1000 IU vitamin D3 + placebo OJ
Dietary Supplement: Vitamin D3
capsule, 1000 IU
Active Comparator: 1000 IU vitamin D2 + placebo OJ
1000 IU vitamin D2 + placebo OJ
Dietary Supplement: Vitamin D2
capsule, 1000 IU

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778114

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Michael F Holick, PhD, MD Boston University
Study Director: Rachael M Biancuzzo, BS, MA Boston University
  More Information

Publications:

Responsible Party: Michael F. Holick, Michael . Holick PhD, MD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01778114     History of Changes
Other Study ID Numbers: H-26117
Study First Received: January 23, 2013
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Vitamin D2
Vitamin D3
Vitamin D
Orange Juice

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014