Vitamin D DeficiencyNCT01778114
Availability of Vitamin D in Orange Juice
A study testing Vitamin D2 in orange juice, Vitamin D3 in orange juice and Vitamin D2 in people with Vitamin D Deficiency, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D2 in orange juice, Vitamin D3 in orange juice and Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adults of all races ages 18 years and older
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D2 in orange juice, Vitamin D3 in orange juice, Vitamin D2, Vitamin D3, Placebo
- Keywords
- Vitamin D2, Vitamin D3, Vitamin D, Orange Juice
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2 in orange juiceDietary supplement
1000 IU dose
Vitamin D3 in orange juiceDietary supplement
1000 IU
Vitamin D2Dietary supplement
capsule, 1000 IU
Vitamin D3Dietary supplement
capsule, 1000 IU
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo + orange juice without vitamin D | Placebo comparator | Placebo + orange juice without vitamin D Receives: Other: Placebo |
| Placebo + 1000 IU vitamin D3 in OJ | Experimental | Vitamin D3 in orange juice Receives: Dietary Supplement: Vitamin D3 in orange juice |
| Placebo + 1000 IU vitamin D2 in OJ | Experimental | Vitamin D2 in orange juice Receives: Dietary Supplement: Vitamin D2 in orange juice |
| 1000 IU vitamin D3 + placebo OJ | Active comparator | 1000 IU vitamin D3 + placebo OJ Receives: Dietary Supplement: Vitamin D3 |
| 1000 IU vitamin D2 + placebo OJ | Active comparator | 1000 IU vitamin D2 + placebo OJ Receives: Dietary Supplement: Vitamin D2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of 25(OH)D levels after ingestion of 1,000 IU of vitamin D2 or vitamin D3 in a capsule
Measured: 11 weeks
Secondary outcomes (1)
Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael F. Holick, Boston University
- Investigators
- Michael F Holick, PhD, MD, Principal investigator, Boston UniversityRachael M Biancuzzo, BS, MA, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778114
- Sponsor's protocol ID
- H-26117
- Status last verified
- Mar 2017
- First submitted
- 23 Jan 2013
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.
PubMed 16529140Holick MF; New Collective Author. Sunlight "D"ilemma: risk of skin cancer or bone disease and muscle weakness. Lancet. 2001 Jan 6;357(9249):4-6. doi: 10.1016/S0140-6736(00)03560-1. No abstract available.
PubMed 11197362Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK109825/
PubMed 23115811Webb AR, Kline L, Holick MF. Influence of season and latitude on the cutaneous synthesis of vitamin D3: exposure to winter sunlight in Boston and Edmonton will not promote vitamin D3 synthesis in human skin. J Clin Endocrinol Metab. 1988 Aug;67(2):373-8. doi: 10.1210/jcem-67-2-373.
PubMed 2839537Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.
PubMed 9519960Tangpricha V, Koutkia P, Rieke SM, Chen TC, Perez AA, Holick MF. Fortification of orange juice with vitamin D: a novel approach for enhancing vitamin D nutritional health. Am J Clin Nutr. 2003 Jun;77(6):1478-83. doi: 10.1093/ajcn/77.6.1478.
PubMed 12791627Holick MF, Siris ES, Binkley N, Beard MK, Khan A, Katzer JT, Petruschke RA, Chen E, de Papp AE. Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab. 2005 Jun;90(6):3215-24. doi: 10.1210/jc.2004-2364. Epub 2005 Mar 29.
PubMed 15797954Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. doi: 10.1093/ajcn/77.1.204.
PubMed 12499343Armas LA, Hollis BW, Heaney RP. Vitamin D2 is much less effective than vitamin D3 in humans. J Clin Endocrinol Metab. 2004 Nov;89(11):5387-91. doi: 10.1210/jc.2004-0360.
PubMed 15531486Trang HM, Cole DE, Rubin LA, Pierratos A, Siu S, Vieth R. Evidence that vitamin D3 increases serum 25-hydroxyvitamin D more efficiently than does vitamin D2. Am J Clin Nutr. 1998 Oct;68(4):854-8. doi: 10.1093/ajcn/68.4.854.
PubMed 9771862Biancuzzo RM, Young A, Bibuld D, Cai MH, Winter MR, Klein EK, Ameri A, Reitz R, Salameh W, Chen TC, Holick MF. Fortification of orange juice with vitamin D(2) or vitamin D(3) is as effective as an oral supplement in maintaining vitamin D status in adults. Am J Clin Nutr. 2010 Jun;91(6):1621-6. doi: 10.3945/ajcn.2009.27972. Epub 2010 Apr 28.
PubMed 20427729
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin D2 and Vitamin D3 in Supplements Compared to Vitamin D3 and Vitamin D2 in Fortified Orange Juice
- ClinicalTrials.gov ID
- NCT01778114
- Acronym / sponsor ID
- H-26117
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D2, Vitamin D3, Vitamin D, Orange Juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo + orange juice without vitamin D | Placebo comparator | Other: PlaceboPlacebo + orange juice without vitamin D |
| Placebo + 1000 IU vitamin D3 in OJ | Experimental | Dietary Supplement: Vitamin D3 in orange juiceVitamin D3 in orange juice |
| Placebo + 1000 IU vitamin D2 in OJ | Experimental | Dietary Supplement: Vitamin D2 in orange juiceVitamin D2 in orange juice |
| 1000 IU vitamin D3 + placebo OJ | Active comparator | Dietary Supplement: Vitamin D31000 IU vitamin D3 + placebo OJ |
| 1000 IU vitamin D2 + placebo OJ | Active comparator | Dietary Supplement: Vitamin D21000 IU vitamin D2 + placebo OJ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female adults of all races ages 18 years and older
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2 in orange juice1000 IU dose | Dietary supplement | Placebo + 1000 IU vitamin D2 in OJ |
| Vitamin D3 in orange juice1000 IU | Dietary supplement | Placebo + 1000 IU vitamin D3 in OJ |
| Vitamin D2capsule, 1000 IU | Dietary supplement | 1000 IU vitamin D2 + placebo OJ |
| Vitamin D3capsule, 1000 IU | Dietary supplement | 1000 IU vitamin D3 + placebo OJ |
| PlaceboPlacebo | Other | Placebo + orange juice without vitamin D |
Primary outcome
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
1 secondary outcome
Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 16529140Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.
- Background: PubMed 11197362Holick MF; New Collective Author. Sunlight "D"ilemma: risk of skin cancer or bone disease and muscle weakness. Lancet. 2001 Jan 6;357(9249):4-6. doi: 10.1016/S0140-6736(00)03560-1. No abstract available.
- Background: PubMed 23115811Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK109825/
- Background: PubMed 2839537Webb AR, Kline L, Holick MF. Influence of season and latitude on the cutaneous synthesis of vitamin D3: exposure to winter sunlight in Boston and Edmonton will not promote vitamin D3 synthesis in human skin. J Clin Endocrinol Metab. 1988 Aug;67(2):373-8. doi: 10.1210/jcem-67-2-373.
- Background: PubMed 9519960Malabanan A, Veronikis IE, Holick MF. Redefining vitamin D insufficiency. Lancet. 1998 Mar 14;351(9105):805-6. doi: 10.1016/s0140-6736(05)78933-9. No abstract available.
- Background: PubMed 12791627Tangpricha V, Koutkia P, Rieke SM, Chen TC, Perez AA, Holick MF. Fortification of orange juice with vitamin D: a novel approach for enhancing vitamin D nutritional health. Am J Clin Nutr. 2003 Jun;77(6):1478-83. doi: 10.1093/ajcn/77.6.1478.
- Background: PubMed 15797954Holick MF, Siris ES, Binkley N, Beard MK, Khan A, Katzer JT, Petruschke RA, Chen E, de Papp AE. Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab. 2005 Jun;90(6):3215-24. doi: 10.1210/jc.2004-2364. Epub 2005 Mar 29.
- Background: PubMed 12499343Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. doi: 10.1093/ajcn/77.1.204.
- Background: PubMed 15531486Armas LA, Hollis BW, Heaney RP. Vitamin D2 is much less effective than vitamin D3 in humans. J Clin Endocrinol Metab. 2004 Nov;89(11):5387-91. doi: 10.1210/jc.2004-0360.
- Background: PubMed 9771862Trang HM, Cole DE, Rubin LA, Pierratos A, Siu S, Vieth R. Evidence that vitamin D3 increases serum 25-hydroxyvitamin D more efficiently than does vitamin D2. Am J Clin Nutr. 1998 Oct;68(4):854-8. doi: 10.1093/ajcn/68.4.854.
- Results publication: PubMed 20427729Biancuzzo RM, Young A, Bibuld D, Cai MH, Winter MR, Klein EK, Ameri A, Reitz R, Salameh W, Chen TC, Holick MF. Fortification of orange juice with vitamin D(2) or vitamin D(3) is as effective as an oral supplement in maintaining vitamin D status in adults. Am J Clin Nutr. 2010 Jun;91(6):1621-6. doi: 10.3945/ajcn.2009.27972. Epub 2010 Apr 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F Holick, PhD, MD principal investigator
Boston University
Rachael M Biancuzzo, BS, MA study director
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D2 in orange juice, Vitamin D3 in orange juice and Vitamin D2 in people with Vitamin D Deficiency, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778114, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.