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

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ClinicalTrials.gov Identifier: NCT02422784
Recruitment Status : Withdrawn
First Posted : April 21, 2015
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Canada Manitoba Agri-Food Research and Development Initiative
Information provided by (Responsible Party):
University of Manitoba

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Rooibos Iced-Tea (Control) Dietary Supplement: Rooibos Tea - Vitamin D3 Dietary Supplement: Rooibos Tea- Vitamin D3 & Calcium Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422784


Locations
Canada, Manitoba
St. Boniface Hospital, Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Canada Manitoba Agri-Food Research and Development Initiative
Investigators
Principal Investigator: Carla Taylor, PhD University of Manitoba

Additional Information:
Publications:
Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02422784     History of Changes
Other Study ID Numbers: B2013:045
B2013:045 ( Other Identifier: University of Manitoba Biomedical Research Ethics Board )
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: March 2016

Keywords provided by University of Manitoba:
Vitamin D insufficient
rooibos tea
calcium

Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamins
Vitamin D
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents