Vitamin D Deficiency
Conditions
Keywords
Vitamin D2, Vitamin D3, Vitamin D, Orange Juice
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.
Interventions
DIETARY_SUPPLEMENTVitamin D2 in orange juice
1000 IU dose
DIETARY_SUPPLEMENTVitamin D3 in orange juice
1000 IU
DIETARY_SUPPLEMENTVitamin D2
capsule, 1000 IU
DIETARY_SUPPLEMENTVitamin D3
capsule, 1000 IU
OTHERPlacebo
Placebo
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice | 11 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare 25(OH)D levels in subjects taking vitamin D2 versus vitamin D3 | 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. |
| Determine serum 1,25(OH)2D levels | 11 weeks | — |
Countries
United States
Outcome results
None listed