Availability of Vitamin D in Orange Juice

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D2 in orange juice
* Dietary Supplement: Vitamin D3 in orange juice
* Dietary Supplement: Vitamin D2
* Dietary Supplement: Vitamin D3
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo + orange juice without vitamin D<br>Placebo + orange juice without vitamin D | Other: Placebo<br>* Placebo<br>|
| Experimental: Placebo + 1000 IU vitamin D3 in OJ<br>Vitamin D3 in orange juice | Dietary Supplement: Vitamin D3 in orange juice<br>* 1000 IU<br>|
| Experimental: Placebo + 1000 IU vitamin D2 in OJ<br>Vitamin D2 in orange juice | Dietary Supplement: Vitamin D2 in orange juice<br>* 1000 IU dose<br>|
| Active Comparator: 1000 IU vitamin D3 + placebo OJ<br>1000 IU vitamin D3 + placebo OJ | Dietary Supplement: Vitamin D3<br>* capsule, 1000 IU<br>|
| Active Comparator: 1000 IU vitamin D2 + placebo OJ<br>1000 IU vitamin D2 + placebo OJ | Dietary Supplement: Vitamin D2<br>* capsule, 1000 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of 25(OH)D levels after ingestion of 1,000 IU of vitamin D2 or vitamin D3 in a capsule |  | 11 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D2, Vitamin D3, Vitamin D, Orange Juice