Effects of Vitamin D Fortification on Vitamin D Metabolite Profiles and Status in Vitamin D Insufficient Individuals (VITD-2013)

February 22, 2017 updated by: University of Manitoba

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface Hospital, Asper Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A. Inclusion Criteria for Objective 1 (Part One):

  1. Adult volunteers, male or female, between 19 and 50 years of age;
  2. Body mass index (BMI) ≥20 and ≤30 kg/m2 (normal to overweight);
  3. Must be on a stable regime for the past three months, if taking vitamin and mineral/dietary/herbal supplements; and
  4. Willing to provide informed consent.

B. Inclusion Criteria for Objective 2 (Part Two):

  1. Adult volunteers, male or female, between 19 and 50 years of age;
  2. Body mass index (BMI) ≥20 and ≤30 kg/m2 (normal to overweight);
  3. Must be on a stable regime for the past three months, if taking vitamin and mineral/dietary/herbal supplements;
  4. Vitamin D insufficient (serum 25(OH)D concentrations ≥30 and ≤75 nmol/L);
  5. Willing to comply with protocol requirements; and
  6. Willing to provide informed consent.

Exclusion Criteria:

  1. Take a vitamin D or calcium supplement within the last three months before the start date of the study, or during the study;
  2. History of vitamin D deficiency (serum 25(OH)D concentration <30 nmol/L);
  3. History of hypocalcaemia;
  4. Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
  5. Taking any medication (with the exception of birth control);
  6. Daily consumption of more than three servings of dairy products;
  7. Undergone significant sun exposure one month before start date of the study;
  8. Use or have used a tanning booth one month before start date of the study, or during the study;
  9. Plan to travel to a sunny climate during the study;
  10. Currently smoking or have smoked within the last six months before start date of the study, or during the study;
  11. Have allergies to tea products;
  12. Pregnant or lactating; and
  13. Consume excessive alcohol (>10 drinks/week for women, >15 drinks/week for men).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 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.
Dietary supplement: 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.
Active Comparator: Rooibos Tea - Vitamin D3
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.
Dietary supplement: Rooibos Tea - Vitamin D3
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.
Active Comparator: Rooibos Tea- Vitamin D3 & Calcium
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.
Dietary supplement: Rooibos Tea- Vitamin D3 & Calcium
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Screening Visit (Day 0) - Phase 1
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.
6 Weeks (Phase II)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Effects of Vitamin D3 Fortification on markers of vitamin D of vitamin D insufficient individuals
Time Frame: 6 Weeks (Phase II)
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.
6 Weeks (Phase II)
The Effects of vitamin D3 Fortification on calcium metabolism of Vitamin D Insufficient Individuals.
Time Frame: 6 Weeks (Phase II)
To determine the effects of 6 weeks of vitamin D3 fortification on calcium metabolism in plasma/serum and urine of vitamin D insufficient individuals.
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)
Determine the effects of vitamin D3 fortification on the vitamin D metabolite profile in plasma/serum and urine of vitamin D insufficient individuals.
6 Weeks (Phase II)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canada Manitoba Agri-Food Research and Development Initiative

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carla Taylor, PhD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2013:045 (Other Identifier: University of Manitoba Biomedical Research Ethics Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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