Effects of Vitamin D Fortification on Vitamin D Metabolite Profiles and Status in Vitamin D Insufficient Individuals

NCT02422784 | Withdrawn Phase 1

• 1 other identifier: B2013:045
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D insufficient; rooibos tea; calcium

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 Weeks (Phase II)

Secondary Outcomes (3)

• The Effects of Vitamin D3 Fortification on markers of vitamin D of vitamin D insufficient individuals

  6 Weeks (Phase II)

• The Effects of vitamin D3 Fortification on calcium metabolism 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.

  6 Weeks (Phase II)

Study Arms (3)

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.

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.

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.

Dietary Supplement: Rooibos Tea- Vitamin D3 & Calcium

Interventions

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.

Control

Rooibos Tea - Vitamin D3 DIETARY_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

Rooibos Tea- Vitamin D3 & Calcium DIETARY_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.

Rooibos Tea- Vitamin D3 & Calcium

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• University of Manitoba: lead
• Canada Manitoba Agri-Food Research and Development Initiative: collaborator

Study Sites (1)

St. Boniface Hospital, Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (5)

• 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.

  PMID: 15585792 BACKGROUND

• Tangpricha 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.

  PMID: 12791627 BACKGROUND

• Ding 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.

  PMID: 20628873 BACKGROUND

• Luque 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.

  PMID: 10704005 BACKGROUND

• Stalmach 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.

  PMID: 19534535 BACKGROUND

Related Links

• Canadian Centre for Agri-Food Research in Health and Medicine

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Calcium

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Carla Taylor, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: April 21, 2015
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 23, 2017

Record last verified: 2016-03

Locations

CA (1)