Vitamin D DeficiencyNCT01909063
A Randomized Controlled Trial Testing The Effect Of A Multi-Nutrient Fortified Juice
A study testing Vitamin D and Vitamin D, Vitamin E, and Vitamin A in people with Vitamin D Deficiency and Hypovitaminosis A, run by Boston University at 1 site in United States.
Trial summary
The goal of this investigator-initiated study is to determine whether the fortification of orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A, and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at Boston University Medical Center. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Hypovitaminosis A, Vitamin E Deficiency
- What is being tested?
- Vitamin D and Vitamin D, Vitamin E, and Vitamin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2008
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Male and female children of all races with ages between 6 and 10
Who cannot join
- History of rickets
- History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat Malabsorption Syndrome, Crohn's Disease)
- History of severe medical illness, including renal failure (decrease 2/3 kidney function)
- Allergies to orange juice
- Any medical conditions in which it is not advisable to receive two 8 oz. glasses of orange juice per day
- History of Diabetes
- Currently taking, or having taken less than one month prior to start of study, a prescription vitamin D
- Unwilling to consent/assent to this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Testing the Effect of a Multi-nutrient Fortified Juice
The goal of this investigator-initiated study is to determine whether the fortification of orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A, and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at Boston University Medical Center. Circulating concentrations of 25-hydroxyvitamin D [25(OH)D], vitamin A, and vitamin E before, will be measured at mid-intervention (week 6), and after a period of twelve weeks. This study plans to recruit 180 male and female subjects between the ages of 6 and 10. An informed consent will be explained and discussed with the subjects and their parents/guardians willing to participate in the study. The study will be twelve weeks. Blood will be drawn during the initial visit, mid-intervention (week 6), and week 12. Dietary intake will be assessed at baseline and at the conclusion of the 12-week intervention using a 3-day food record. The subjects will be randomized in a double-blinded manner via an electronically shuffled listed. Subjects will be randomized to receive one of three beverages: (1) calcium plus vitamin D fortified orange juice (intervention A), (2) calcium plus vitamins D, A, and E fortified orange juice (intervention B) or (3) calcium-only fortified orange juice (controls). Subjects in all groups will drink two 8-oz. glasses of juice at least six hours apart (morning and afternoon) per day for a period of 12 weeks. Subjects randomized to intervention A will receive 200 IU vitamin D and 700 mg of calcium per day in 2 glasses of juice, intervention B will receive 200 IU vitamin D, 12 IU vitamin E, 2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of juice, while controls will receive 700 mg of calcium per day in 2 glasses of juice. A blood sample will be obtained before the subjects begin drinking the orange juice and at week 12 to determine levels of 25(OH)D which is a measure of vitamin D status. Blood will also be used for determining osteocalcin, parathyroid hormone (PTH), alkaline phosphatase, phosphorus, calcium, C-telopeptide (CTX), albumin, vitamin A, and vitamin E. A blood sample will also be obtained at week 6 for 25(OH)D and PTH.
Read the detailed description
This is an investigator-initiated double-blinded study in which one hundred and eighty male and female subjects ages 6 to 10 will be recruited from the Division of Pediatrics at Boston University Medical Center. Potential volunteers will undergo a screening process to ensure that inclusion and exclusion criteria are met. A general medical history will be taken before the study starts. A baseline biochemical profile (blood) including calcium, phosphorus, osteocalcin, alkaline phosphatase, C-telopeptide (CTX), 25(OH)D, PTH, albumin, vitamin A, and vitamin E will be determined after the study is completed. The amount of blood estimated to be drawn on the first visit is 27 ml. Dietary intake will be assessed from 3 day food records via NDS-Minnesota Database by Dr. Christine Economos, Friedman School of Nutrition Science and Policy at Tufts University. Once the subject has met the inclusion criteria, he/she will receive two gallons of orange juice via a delivery service to their home. He/she will be instructed to drink two 8 oz. glasses of orange juice a day and record each glass of juice that was drunk; stickers and calendars will be provided. A delivery service will be used to deliver juice to parents/caregiver biweekly. Signature and log sheets of deliveries will be maintained. A glass that has a mark designating eight ounces will be provided to the subject so that the amount of orange juice that is drunk is measured. Sixty subjects will receive intervention A, sixty subjects will receive intervention B, and sixty subjects will receive intention C. Subjects randomized to intervention A will receive juice that contains 200 IU of vitamin D and 700 mg of calcium per day. Subjects randomized to intervention B will receive 200 IU vitamin D, 12 IU vitamin E, 2000 IU vitamin A as beta-carotene, and 700 mg of calcium per day. Subjects randomized to intervention C will receive 700 mg calcium per day. A venous blood sample of 27 ml [two red top tubes (10ccs each) and one purple top tube (7ccs)] will be obtained at the initial and final visits. 25(OH)D, PTH, calcium, phosphorus, osteocalcin, C-telopeptide(CTX), alkaline phosphatase, albumin, vitamin A, and vitamin E will be measured from the blood samples. During the mid-intervention blood draw (week 6) 10mL of blood will be drawn and 25(OH)D and PTH will be measured. The study will consist of 12 weeks of drinking two eight-ounce glasses of orange juice a day (one in the am and one in the pm).
- Being tested
- Vitamin D, Vitamin D, Vitamin E, and Vitamin A, Control, 700 mg Calcium
- Medical subject headings
- Vitamin D Deficiency, Avitaminosis, Vitamin E Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Fortification of orange juice with 200 IU vitamin D to be drunk twice per day for 12 weeks
Vitamin D, Vitamin E, and Vitamin ADietary supplement
Fortification of orange juice with Vitamin D, Vitamin E, and Vitamin A to be drunk twice per day for 12 weeks
Control, 700 mg CalciumDietary supplement
Orange juice with 700 mg calcium to be drunk twice per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 200 IU vitamin D and 700 mg of calcium per day in 2 glasses of juice per day for 2 weeks Receives: Dietary Supplement: Vitamin D |
| Arm B | Experimental | 200 IU vitamin D, 12 IU vitamin E, 2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of juice
Vitamin D, Vitamin E, and Vitamin A Receives: Dietary Supplement: Vitamin D, Vitamin E, and Vitamin A |
| Arm C | Placebo comparator | Control, 700 mg of calcium per day in 2 glasses of juice
Control, 700 mg Calcium Receives: Dietary Supplement: Control, 700 mg Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve Vitamin A, Vitamin E, and Vitamin D Status in Children
The primary outcome of this study is to determine if fortification of orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A, and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at Boston University Medical Center.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael F. Holick, Boston Medical Center
- Investigators
- Micahel F Holick, PhD, MD, Principal investigator, BUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909063
- Sponsor's protocol ID
- Multinutrient Fortified Juice
- Status last verified
- Feb 2017
- First submitted
- 25 Jun 2012
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Testing the Effect of a Multi-nutrient Fortified Juice
- ClinicalTrials.gov ID
- NCT01909063
- Acronym / sponsor ID
- Multinutrient Fortified Juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 26 Jul 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 goal of this investigator-initiated study is to determine whether the fortification of orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A, and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at Boston University Medical Center. Circulating concentrations of 25-hydroxyvitamin D [25(OH)D], vitamin A, and vitamin E before, will be measured at mid-intervention (week 6), and after a period of twelve weeks. This study plans to recruit 180 male and female subjects between the ages of 6 and 10. An informed consent will be explained and discussed with the subjects and their parents/guardians willing to participate in the study. The study will be twelve weeks. Blood will be drawn during the initial visit, mid-intervention (week 6), and week 12. Dietary intake will be assessed at baseline and at the conclusion of the 12-week intervention using a 3-day food record. The subjects will be randomized in a double-blinded manner via an electronically shuffled listed. Subjects will be randomized to receive one of three beverages: (1) calcium plus vitamin D fortified orange juice (intervention A), (2) calcium plus vitamins D, A, and E fortified orange juice (intervention B) or (3) calcium-only fortified orange juice (controls). Subjects in all groups will drink two 8-oz. glasses of juice at least six hours apart (morning and afternoon) per day for a period of 12 weeks. Subjects randomized to intervention A will receive 200 IU vitamin D and 700 mg of calcium per day in 2 glasses of juice, intervention B will receive 200 IU vitamin D, 12 IU vitamin E, 2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of juice, while controls will receive 700 mg of calcium per day in 2 glasses of juice. A blood sample will be obtained before the subjects begin drinking the orange juice and at week 12 to determine levels of 25(OH)D which is a measure of vitamin D status. Blood will also be used for determining osteocalcin, parathyroid hormone (PTH), alkaline phosphatase, phosphorus, calcium, C-telopeptide (CTX), albumin, vitamin A, and vitamin E. A blood sample will also be obtained at week 6 for 25(OH)D and PTH.
Detailed description
This is an investigator-initiated double-blinded study in which one hundred and eighty male and female subjects ages 6 to 10 will be recruited from the Division of Pediatrics at Boston University Medical Center. Potential volunteers will undergo a screening process to ensure that inclusion and exclusion criteria are met. A general medical history will be taken before the study starts. A baseline biochemical profile (blood) including calcium, phosphorus, osteocalcin, alkaline phosphatase, C-telopeptide (CTX), 25(OH)D, PTH, albumin, vitamin A, and vitamin E will be determined after the study is completed. The amount of blood estimated to be drawn on the first visit is 27 ml. Dietary intake will be assessed from 3 day food records via NDS-Minnesota Database by Dr. Christine Economos, Friedman School of Nutrition Science and Policy at Tufts University. Once the subject has met the inclusion criteria, he/she will receive two gallons of orange juice via a delivery service to their home. He/she will be instructed to drink two 8 oz. glasses of orange juice a day and record each glass of juice that was drunk; stickers and calendars will be provided. A delivery service will be used to deliver juice to parents/caregiver biweekly. Signature and log sheets of deliveries will be maintained. A glass that has a mark designating eight ounces will be provided to the subject so that the amount of orange juice that is drunk is measured. Sixty subjects will receive intervention A, sixty subjects will receive intervention B, and sixty subjects will receive intention C. Subjects randomized to intervention A will receive juice that contains 200 IU of vitamin D and 700 mg of calcium per day. Subjects randomized to intervention B will receive 200 IU vitamin D, 12 IU vitamin E, 2000 IU vitamin A as beta-carotene, and 700 mg of calcium per day. Subjects randomized to intervention C will receive 700 mg calcium per day. A venous blood sample of 27 ml [two red top tubes (10ccs each) and one purple top tube (7ccs)] will be obtained at the initial and final visits. 25(OH)D, PTH, calcium, phosphorus, osteocalcin, C-telopeptide(CTX), alkaline phosphatase, albumin, vitamin A, and vitamin E will be measured from the blood samples. During the mid-intervention blood draw (week 6) 10mL of blood will be drawn and 25(OH)D and PTH will be measured. The study will consist of 12 weeks of drinking two eight-ounce glasses of orange juice a day (one in the am and one in the pm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Dietary Supplement: Vitamin D200 IU vitamin D and 700 mg of calcium per day in 2 glasses of juice per day for 2 weeks |
| Arm B | Experimental | Dietary Supplement: Vitamin D, Vitamin E, and Vitamin A200 IU vitamin D, 12 IU vitamin E, 2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of juice Vitamin D, Vitamin E, and Vitamin A |
| Arm C | Placebo comparator | Dietary Supplement: Control, 700 mg CalciumControl, 700 mg of calcium per day in 2 glasses of juice Control, 700 mg Calcium |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Male and female children of all races with ages between 6 and 10
Key exclusion criteria (8 listed)
- History of rickets
- History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat Malabsorption Syndrome, Crohn's Disease)
- History of severe medical illness, including renal failure (decrease 2/3 kidney function)
- Allergies to orange juice
- Any medical conditions in which it is not advisable to receive two 8 oz. glasses of orange juice per day
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 DFortification of orange juice with 200 IU vitamin D to be drunk twice per day for 12 weeks | Dietary supplement | Arm A |
| Vitamin D, Vitamin E, and Vitamin AFortification of orange juice with Vitamin D, Vitamin E, and Vitamin A to be drunk twice per day for 12 weeks | Dietary supplement | Arm B |
| Control, 700 mg CalciumOrange juice with 700 mg calcium to be drunk twice per day for 12 weeks | Dietary supplement | Arm C |
Primary outcome
Improve Vitamin A, Vitamin E, and Vitamin D Status in Children
Time frame: 12 weeks
The primary outcome of this study is to determine if fortification of orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A, and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at Boston University Medical Center.
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 28 Feb 2017.
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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.
Micahel F Holick, PhD, MD principal investigator
BUMC
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 D and Vitamin D, Vitamin E, and Vitamin A in people with Vitamin D Deficiency and Hypovitaminosis A, 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 8 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 28 Feb 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?
Improve Vitamin A, Vitamin E, and Vitamin D Status in Children (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2017.