Vitamin D DeficiencyPhase 1VITD-2013NCT02422784
Effects of Vitamin D Fortification on Vitamin D Metabolite Profiles and Status in Vitamin D Insufficient Individuals
A Phase 1 study testing Rooibos Tea - Vitamin D3 and Rooibos Tea- Vitamin D3 & Calcium in people with Vitamin D Deficiency, run by University of Manitoba at 1 site in Canada.
Trial summary
This is a cross-sectional study designed to compare plasma/serum and urine vitamin D metabolite profiles of vitamin D sufficient and insufficient individuals. There are two phases of this study. Phase 1 - Consented study participants will attend a screening visit and provide a fasting blood and urine sample. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Rooibos Tea - Vitamin D3 and Rooibos Tea- Vitamin D3 & Calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Jun 2018
- Phase
- Phase 1
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion Criteria for Objective 1 (Part One):
- Adult volunteers, male or female, between 19 and 50 years of age;
- Body mass index (BMI) ≥20 and ≤30 kg/m2 (normal to overweight);
- Must be on a stable regime for the past three months, if taking vitamin and mineral/dietary/herbal supplements; and
- Willing to provide informed consent.
- Inclusion Criteria for Objective 2 (Part Two):
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- Adult volunteers, male or female, between 19 and 50 years of age;
- Body mass index (BMI) ≥20 and ≤30 kg/m2 (normal to overweight);
- Must be on a stable regime for the past three months, if taking vitamin and mineral/dietary/herbal supplements;
- Vitamin D insufficient (serum 25(OH)D concentrations ≥30 and ≤75 nmol/L);
- Willing to comply with protocol requirements; and
- Willing to provide informed consent.
Who cannot join
- Take a vitamin D or calcium supplement within the last three months before the start date of the study, or during the study;
- History of vitamin D deficiency (serum 25(OH)D concentration <30 nmol/L);
- History of hypocalcaemia;
- Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- Taking any medication (with the exception of birth control);
- Daily consumption of more than three servings of dairy products;
Show all 13Show fewer
- Undergone significant sun exposure one month before start date of the study;
- Use or have used a tanning booth one month before start date of the study, or during the study;
- Plan to travel to a sunny climate during the study;
- Currently smoking or have smoked within the last six months before start date of the study, or during the study;
- Have allergies to tea products;
- Pregnant or lactating; and
- Consume excessive alcohol (>10 drinks/week for women, >15 drinks/week for men).
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Boniface Hospital, Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Double-Blind, Randomized, Control Study to Examine the Effects of Vitamin D Fortification on Vitamin D Metabolite Profiles and Status in Vitamin D Insufficient Individuals.
This is a cross-sectional study designed to compare plasma/serum and urine vitamin D metabolite profiles of vitamin D sufficient and insufficient individuals.
There are two phases of this study.
Read more
Phase 1 - Consented study participants will attend a screening visit and provide a fasting blood and urine sample. Those individuals who are vitamin D insufficient based on serum 25(OH)D concentrations will be invited to participate in Phase II
Phase II - is a double-blind, randomized, control study designed to examine vitamin D status in vitamin D insufficient individuals consuming a water-soluble form of vitamin D3. Eligible participants will be asked to consume one of three beverages: i) rooibos iced-tea (control); ii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3; or iii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3 and 360 mg calcium at 240 mL of iced-tea consumed daily for 6 weeks. Participants will attend 6 weekly visits following baseline and provide a fasting blood sample for assessment of serum 25(OH)D concentrations.
Objectives: 1) To investigate plasma/serum and urine vitamin D metabolite profiles in vitamin D sufficient and insufficient individuals; and 2) To determine the effects of vitamin D3 fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations, markers of vitamin D and calcium metabolism, and vitamin D metabolite profile in plasma/serum and urine of vitamin D insufficient individuals.
Read the detailed description
Health individuals from the general public will be recruited into this cross-sectional study designed to compare plasma/serum and urine vitamin D metabolite profiles of those identified as vitamin D sufficient and insufficient individuals.
There are two objectives:
Objective 1: To investigate plasma/serum and urine vitamin D metabolite profiles in vitamin D sufficient and insufficient individuals; N=20 and will consist of 10 individuals identified as vitamin D insufficient and 10 individuals identified as vitamin D deficient individuals.
Objective 2: To determine the effects of vitamin D3 fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations, markers of vitamin D and calcium metabolism, and vitamin D metabolite profile in plasma/serum and urine of vitamin D insufficient individuals. N=45.
To achieve the objectives, the study will be conducted in two phases:
Phase 1 - Healthy males or females, ≥19 and ≤50 years of age, will be recruited from the general public. Consented study participants will provide a fasting blood and urine sample for the purpose of determination of vitamin D status (insufficient vs. deficient) based on serum 25(OH)D concentrations. Forty-five (45) individuals identified as vitamin D insufficient (having a serum 25(OH)D concentration ≥30 and ≤75 nmol/L) will proceed to phase II. A N=20 (10 vitamin D insufficient and 10 vitamin D deficient) will also be identified to satisfy objective 1.
Phase II - is a double-blind, randomized, control study designed to examine vitamin D status in vitamin D insufficient individuals consuming a water-soluble form of vitamin D3. Eligible participants will randomized to consume one of three beverages: i) rooibos iced-tea (control); ii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3; or iii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3 and 360 mg calcium at 240 mL of iced-tea consumed daily for 6 weeks. Both researchers and participants will be blinded to the beverage group assigned to each participant. Participants will then attend 6 weekly visits following the baseline visit to provide fasting blood samples for assessment of serum 25(OH)D concentrations.
Analysis of intact-PTH, alkaline-phosphatase, calcium, phosphorus, CRP, TAP and vitamin D metabolite profile and a urine sample will also be obtained for assessment of N-telopeptide and vitamin D metabolite profile will also occur at Baseline and Week 6. Fasting blood samples collected at week 3 will be used for additional assessment of serum alkaline phosphatase, calcium and phosphorus. A 3-day Food Record will be provided at week 3.
Vitamin D insufficient participants will be stratified according to their serum 25(OH)D concentrations (≥30 and ≤50, or >50 and ≤75 nmol/L) after screening and prior to the beverage study to ensure that a range of lower and higher serum 25(OH)D concentrations are represented in each beverage group.
- Conditions
- Vitamin D Deficiency
- Being tested
- Rooibos Iced-Tea (Control), Rooibos Tea - Vitamin D3, Rooibos Tea- Vitamin D3 & Calcium
- Keywords
- Vitamin D insufficient, rooibos tea, calcium
- 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.
Rooibos Iced-Tea (Control)Dietary supplement
Participants will consume 240 mL of Rooibos iced-tea daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits.
Rooibos Tea - Vitamin D3Dietary supplement
Participants will consume 240 mL of Rooibos iced-tea fortified with 1000 IU of water soluable Vitamin D3 daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits.
Rooibos Tea- Vitamin D3 & CalciumDietary supplement
Participants will consume 240 mL of Rooibos iced-tea fortified with 1000 IU of water soluable Vitamin D3 and 360 mg of Calicum daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will be instructed to consume 240 mL of iced-tea daily for 6 weeks. The iced-tea beverages do not contain added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. Receives: Dietary Supplement: Rooibos Iced-Tea (Control) |
| Rooibos Tea - Vitamin D3 | Active comparator | Participants will be instructed to consume 240 mL of iced-tea fortified with 1000 IU water-soluable vitamin D3 daily for 6 weeks. The iced-tea beverages do not contain added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. Receives: Dietary Supplement: Rooibos Tea - Vitamin D3 |
| Rooibos Tea- Vitamin D3 & Calcium | Active comparator | Participants will be instructed to consume 240 mL of Rooibos iced-tea fortified with 1000 IU of water-soluable vitamin D3 and 360 mg of calcium daily for 6 weeks. The iced-tea beverages do not contain added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. Receives: Dietary Supplement: Rooibos Tea- Vitamin D3 & Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma/Serum and Urine Vitamin D Metabolite Profiles of Vitamin D Sufficient and Insufficient Individuals
To investigate plasma/serum and urine vitamin D metabolite profiles in vitamin D sufficient and insufficient individuals.
Measured: Screening Visit (Day 0) - Phase 1
The Effects of Vitamin D Fortification on Serum 25(OH)D in Vitamin D Insufficient Individuals.
To determine the effects of 6 weeks of vitamin D3 fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations of vitamin D insufficient individuals.
Measured: 6 Weeks (Phase II)
Secondary outcomes (3)
The Effects of Vitamin D3 Fortification on markers of vitamin D of vitamin D insufficient individuals
To determine the effects of 6 weeks of vitamin D3 fortification on markers of vitamin D in plasma/serum and urine of vitamin D insufficient individuals.
Measured: 6 Weeks (Phase II)
The Effects of vitamin D3 Fortification on calcium metabolism of Vitamin D Insufficient Individuals.
To determine the effects of 6 weeks of vitamin D3 fortification on calcium metabolism in plasma/serum and urine of vitamin D insufficient individuals.
Measured: 6 Weeks (Phase II)
The Effects of Vitamin D3 Fortification on Vitamin D Metabolite Profile of Vitamin D Insufficient Individuals.
Determine the effects of vitamin D3 fortification on the vitamin D metabolite profile in plasma/serum and urine of vitamin D insufficient individuals.
Measured: 6 Weeks (Phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startJul 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 University of ManitobaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canada Manitoba Agri-Food Research and Development Initiative
- Responsible party
- Sponsor
- Investigators
- Carla Taylor, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422784
- Sponsor's protocol ID
- B2013:045
- Other IDs
- B2013:045
- Acronym
- VITD-2013
- Status last verified
- Mar 2016
- First submitted
- 11 Feb 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Calvo MS, Whiting SJ, Barton CN. Vitamin D fortification in the United States and Canada: current status and data needs. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1710S-6S. doi: 10.1093/ajcn/80.6.1710S.
PubMed 15585792Tangpricha 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 12791627Ding S, Schoenmakers I, Jones K, Koulman A, Prentice A, Volmer DA. Quantitative determination of vitamin D metabolites in plasma using UHPLC-MS/MS. Anal Bioanal Chem. 2010 Sep;398(2):779-89. doi: 10.1007/s00216-010-3993-0. Epub 2010 Jul 14.
PubMed 20628873Luque de Castro MD, Fernandez-Romero JM, Ortiz-Boyer F, Quesada JM. Determination of vitamin D3 metabolites: state-of-the-art and trends. J Pharm Biomed Anal. 1999 Jun;20(1-2):1-17. doi: 10.1016/s0731-7085(99)00027-8.
PubMed 10704005Stalmach A, Mullen W, Pecorari M, Serafini M, Crozier A. Bioavailability of C-linked dihydrochalcone and flavanone glucosides in humans following ingestion of unfermented and fermented rooibos teas. J Agric Food Chem. 2009 Aug 12;57(15):7104-11. doi: 10.1021/jf9011642.
PubMed 19534535
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Control Study to Examine the Effects of Vitamin D Fortification on Vitamin D Metabolite Profiles and Status in Vitamin D Insufficient Individuals.
- ClinicalTrials.gov ID
- NCT02422784
- Acronym / sponsor ID
- VITD-2013 / B2013:045
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D insufficient, rooibos tea, calcium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canada Manitoba Agri-Food Research and Development Initiative
- Study start
- Jul 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Apr 2015 (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.
This is a cross-sectional study designed to compare plasma/serum and urine vitamin D metabolite profiles of vitamin D sufficient and insufficient individuals.
There are two phases of this study.
Phase 1 - Consented study participants will attend a screening visit and provide a fasting blood and urine sample. Those individuals who are vitamin D insufficient based on serum 25(OH)D concentrations will be invited to participate in Phase II
Phase II - is a double-blind, randomized, control study designed to examine vitamin D status in vitamin D insufficient individuals consuming a water-soluble form of vitamin D3. Eligible participants will be asked to consume one of three beverages: i) rooibos iced-tea (control); ii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3; or iii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3 and 360 mg calcium at 240 mL of iced-tea consumed daily for 6 weeks. Participants will attend 6 weekly visits following baseline and provide a fasting blood sample for assessment of serum 25(OH)D concentrations.
Objectives: 1) To investigate plasma/serum and urine vitamin D metabolite profiles in vitamin D sufficient and insufficient individuals; and 2) To determine the effects of vitamin D3 fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations, markers of vitamin D and calcium metabolism, and vitamin D metabolite profile in plasma/serum and urine of vitamin D insufficient individuals.
Detailed description
Health individuals from the general public will be recruited into this cross-sectional study designed to compare plasma/serum and urine vitamin D metabolite profiles of those identified as vitamin D sufficient and insufficient individuals.
There are two objectives:
Objective 1: To investigate plasma/serum and urine vitamin D metabolite profiles in vitamin D sufficient and insufficient individuals; N=20 and will consist of 10 individuals identified as vitamin D insufficient and 10 individuals identified as vitamin D deficient individuals.
Objective 2: To determine the effects of vitamin D3 fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations, markers of vitamin D and calcium metabolism, and vitamin D metabolite profile in plasma/serum and urine of vitamin D insufficient individuals. N=45.
To achieve the objectives, the study will be conducted in two phases:
Phase 1 - Healthy males or females, ≥19 and ≤50 years of age, will be recruited from the general public. Consented study participants will provide a fasting blood and urine sample for the purpose of determination of vitamin D status (insufficient vs. deficient) based on serum 25(OH)D concentrations. Forty-five (45) individuals identified as vitamin D insufficient (having a serum 25(OH)D concentration ≥30 and ≤75 nmol/L) will proceed to phase II. A N=20 (10 vitamin D insufficient and 10 vitamin D deficient) will also be identified to satisfy objective 1.
Phase II - is a double-blind, randomized, control study designed to examine vitamin D status in vitamin D insufficient individuals consuming a water-soluble form of vitamin D3. Eligible participants will randomized to consume one of three beverages: i) rooibos iced-tea (control); ii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3; or iii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3 and 360 mg calcium at 240 mL of iced-tea consumed daily for 6 weeks. Both researchers and participants will be blinded to the beverage group assigned to each participant. Participants will then attend 6 weekly visits following the baseline visit to provide fasting blood samples for assessment of serum 25(OH)D concentrations.
Analysis of intact-PTH, alkaline-phosphatase, calcium, phosphorus, CRP, TAP and vitamin D metabolite profile and a urine sample will also be obtained for assessment of N-telopeptide and vitamin D metabolite profile will also occur at Baseline and Week 6. Fasting blood samples collected at week 3 will be used for additional assessment of serum alkaline phosphatase, calcium and phosphorus. A 3-day Food Record will be provided at week 3.
Vitamin D insufficient participants will be stratified according to their serum 25(OH)D concentrations (≥30 and ≤50, or >50 and ≤75 nmol/L) after screening and prior to the beverage study to ensure that a range of lower and higher serum 25(OH)D concentrations are represented in each beverage group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Rooibos Iced-Tea (Control)Participants will be instructed to consume 240 mL of iced-tea daily for 6 weeks. The iced-tea beverages do not contain added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. |
| Rooibos Tea - Vitamin D3 | Active comparator | Dietary Supplement: Rooibos Tea - Vitamin D3Participants will be instructed to consume 240 mL of iced-tea fortified with 1000 IU water-soluable vitamin D3 daily for 6 weeks. The iced-tea beverages do not contain added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. |
| Rooibos Tea- Vitamin D3 & Calcium | Active comparator | Dietary Supplement: Rooibos Tea- Vitamin D3 & CalciumParticipants will be instructed to consume 240 mL of Rooibos iced-tea fortified with 1000 IU of water-soluable vitamin D3 and 360 mg of calcium daily for 6 weeks. The iced-tea beverages do not contain added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Inclusion Criteria for Objective 1 (Part One):
- Adult volunteers, male or female, between 19 and 50 years of age;
- Body mass index (BMI) ≥20 and ≤30 kg/m2 (normal to overweight);
- Must be on a stable regime for the past three months, if taking vitamin and mineral/dietary/herbal supplements; and
- Willing to provide informed consent.
Key exclusion criteria (13 listed)
- Take a vitamin D or calcium supplement within the last three months before the start date of the study, or during the study;
- History of vitamin D deficiency (serum 25(OH)D concentration <30 nmol/L);
- History of hypocalcaemia;
- Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- Taking any medication (with the exception of birth control);
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 |
|---|---|---|
| Rooibos Iced-Tea (Control)Participants will consume 240 mL of Rooibos iced-tea daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. | Dietary supplement | Control |
| Rooibos Tea - Vitamin D3Participants will consume 240 mL of Rooibos iced-tea fortified with 1000 IU of water soluable Vitamin D3 daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. | Dietary supplement | Rooibos Tea - Vitamin D3 |
| Rooibos Tea- Vitamin D3 & CalciumParticipants will consume 240 mL of Rooibos iced-tea fortified with 1000 IU of water soluable Vitamin D3 and 360 mg of Calicum daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits. | Dietary supplement | Rooibos Tea- Vitamin D3 & Calcium |
Primary outcome
Plasma/Serum and Urine Vitamin D Metabolite Profiles of Vitamin D Sufficient and Insufficient Individuals
Time frame: Screening Visit (Day 0) - Phase 1
To investigate plasma/serum and urine vitamin D metabolite profiles in vitamin D sufficient and insufficient individuals.
The Effects of Vitamin D Fortification on Serum 25(OH)D in Vitamin D Insufficient Individuals.
Time frame: 6 Weeks (Phase II)
To determine the effects of 6 weeks of vitamin D3 fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations of vitamin D insufficient individuals.
3 secondary outcomes
The Effects of Vitamin D3 Fortification on markers of vitamin D of vitamin D insufficient individuals
Time frame: 6 Weeks (Phase II)
The Effects of vitamin D3 Fortification on calcium metabolism of Vitamin D Insufficient Individuals.
Time frame: 6 Weeks (Phase II)
The Effects of Vitamin D3 Fortification on Vitamin D Metabolite Profile of Vitamin D Insufficient Individuals.
Time frame: 6 Weeks (Phase II)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 15585792Calvo MS, Whiting SJ, Barton CN. Vitamin D fortification in the United States and Canada: current status and data needs. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1710S-6S. doi: 10.1093/ajcn/80.6.1710S.
- 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 20628873Ding S, Schoenmakers I, Jones K, Koulman A, Prentice A, Volmer DA. Quantitative determination of vitamin D metabolites in plasma using UHPLC-MS/MS. Anal Bioanal Chem. 2010 Sep;398(2):779-89. doi: 10.1007/s00216-010-3993-0. Epub 2010 Jul 14.
- Background: PubMed 10704005Luque de Castro MD, Fernandez-Romero JM, Ortiz-Boyer F, Quesada JM. Determination of vitamin D3 metabolites: state-of-the-art and trends. J Pharm Biomed Anal. 1999 Jun;20(1-2):1-17. doi: 10.1016/s0731-7085(99)00027-8.
- Background: PubMed 19534535Stalmach A, Mullen W, Pecorari M, Serafini M, Crozier A. Bioavailability of C-linked dihydrochalcone and flavanone glucosides in humans following ingestion of unfermented and fermented rooibos teas. J Agric Food Chem. 2009 Aug 12;57(15):7104-11. doi: 10.1021/jf9011642.
- Canadian Centre for Agri-Food Research in Health and MedicineLink provided by the sponsor.
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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.
Carla Taylor, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rooibos Tea - Vitamin D3 and Rooibos Tea- Vitamin D3 & Calcium in people with Vitamin D Deficiency, run by University of Manitoba at 1 site in Canada.
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 12 inclusion and 13 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: withdrawn, as of the sponsor's last update on 23 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Plasma/Serum and Urine Vitamin D Metabolite Profiles of Vitamin D Sufficient and Insufficient Individuals (time frame: Screening Visit (Day 0) - Phase 1). The study lists 2 primary outcomes in all. 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 NCT02422784, which also lists 5 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 23 Feb 2017.