Vitamin D Deficiency Clinical Trial
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.
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.
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.
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