Availability of Vitamin D in Orange Juice
- Conditions
- Vitamin D Deficiency
- Interventions
- Other: PlaceboDietary Supplement: Vitamin D3 in orange juiceDietary Supplement: Vitamin D2 in orange juiceDietary Supplement: Vitamin D3Dietary Supplement: Vitamin D2
- Registration Number
- NCT01778114
- Lead Sponsor
- Boston University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Male and female adults of all races ages 18 years and older
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + orange juice without vitamin D Placebo Placebo + orange juice without vitamin D Placebo + 1000 IU vitamin D3 in OJ Vitamin D3 in orange juice Vitamin D3 in orange juice Placebo + 1000 IU vitamin D2 in OJ Vitamin D2 in orange juice Vitamin D2 in orange juice 1000 IU vitamin D3 + placebo OJ Vitamin D3 1000 IU vitamin D3 + placebo OJ 1000 IU vitamin D2 + placebo OJ Vitamin D2 1000 IU vitamin D2 + placebo OJ
- Primary Outcome Measures
Name Time Method 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
Name Time Method Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice 11 weeks
Trial Locations
- Locations (1)
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States