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Trial record 66 of 108 for:    CALCIUM CATION

The Influence of Food Matrix Delivery System on the Bioavailability of Vitamin D3 (DFORT)

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ClinicalTrials.gov Identifier: NCT03783273
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

This study investigates the influence of different food matrices on the bioavailability of vitamin D.

Although most vitamin D comes from skin synthesis in response to sun exposure, dietary intake is also important - especially during winter time where there is no endogenous production of vitamin D in Denmark. A way to maintain an adequate vitamin D status is to supplement either as tablets/droplets or as fortified food. However, there seems to be an inter-individual variation in response to supplementation.

This study aims to investigate whether this variation in absorption of vitamin D may depend on delivery system.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D3 Combination Product: Whey protein-complex Other: Water Other: Milk Other: Juice Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A multiple crossover study using a balanced latin square design. Each participant will receive all five treatments with a wash-out period of 10-21 days between each treatment.
Masking: Single (Participant)
Masking Description: Participants will not know if they receive juice with complex-bound vitamin D3 or not.
Primary Purpose: Treatment
Official Title: The Influence of Food Matrix Delivery System on the Bioavailability of Vitamin D3
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Whey protein complex-bound D3 + juice
200 microgram vitamin D3 in a whey protein-complex added to 500 mL of juice.
Dietary Supplement: Vitamin D3
Single dose vitamin D3

Combination Product: Whey protein-complex
Whey protein complex-bound vitamin D3

Other: Juice
500 mL juice

Active Comparator: D3 + juice
200 microgram vitamin D3 added to 500 mL of juice.
Dietary Supplement: Vitamin D3
Single dose vitamin D3

Other: Juice
500 mL juice

Active Comparator: D3 + milk
200 microgram vitamin D3 added to 500 mL of skimmed-milk.
Dietary Supplement: Vitamin D3
Single dose vitamin D3

Other: Milk
500 mL milk

Active Comparator: D3 droplets
200 microgram vitamin D3 as droplets + 500 mL of water.
Dietary Supplement: Vitamin D3
Single dose vitamin D3

Other: Water
500 mL water

Placebo Comparator: No vitamin D
500 mL of Water.
Other: Water
500 mL water




Primary Outcome Measures :
  1. Cmax of vitamin D3 [ Time Frame: 10 hours ]
    Maximum observed concentration of vitamin D3

  2. AUC of vitamin D3 [ Time Frame: 12 hours ]
    Area under the curve for time-concentration relationships during the absorption phase


Secondary Outcome Measures :
  1. Concentration of vitamin D metabolites [ Time Frame: 24 hours ]
    Plasma levels of vitamin D2+D3, 25OHD, 1,25(OH)2D, 24,25(OH)2D and VDBP

  2. Concentration of PTH [ Time Frame: 24 hours ]
    Changes in plasma PTH in response to treatment

  3. Plasma concentration of ion-calcium [ Time Frame: 24 hours ]
    Changes in plasma ionized calcium in response to treatment

  4. Urine concentration of calcium [ Time Frame: 24 hours ]
    Changes in urine calcium in response to treatment

  5. Urine concentration of creatinine [ Time Frame: 24 hours ]
    Changes in urine creatinine in response to treatment

  6. Urine concentration of phosphate [ Time Frame: 24 hours ]
    Changes in urine phosphate in response to treatment

  7. Urine concentration of magnesium [ Time Frame: 24 hours ]
    Changes in urine magnesium in response to treatment

  8. Urine concentration of sodium [ Time Frame: 24 hours ]
    Changes in urine sodium in response to treatment

  9. Urine concentration of potassium [ Time Frame: 24 hours ]
    Changes in urine potassium in response to treatment

  10. Urine osmolality [ Time Frame: 24 hours ]
    Changes in urine osmolality in response to treatment

  11. Systolic and diastolic blood pressure [ Time Frame: 4 hours ]
    Office blood pressure of the upper right arm

  12. Pulse wave velocity [ Time Frame: 4 hours ]
    Assessed by tonometry using SphygmoCor system

  13. Arterial stiffness [ Time Frame: 4 hours ]
    Assessed by tonometry using SphygmoCor system system (Xcel; AtCor Medical, Sydney, NSW, Australia)


Other Outcome Measures:
  1. Body composition [ Time Frame: Week 4 ]
    Assessed by DXA

  2. Areal BMD [ Time Frame: Week 4 ]
    BMD at the lumbar spine, femoral neck and distal forearm assessed by DXA

  3. Bone geometry [ Time Frame: Week 4 ]
    Assessed by HRpQCT of distal tibia and distal radius

  4. Volumetric BMD [ Time Frame: Week 4 ]
    Assessed by HRpQCT of distal tibia and distal radius

  5. Estimated bone strength [ Time Frame: Week 4 ]
    Assessed by HRpQCT of distal tibia and distal radius

  6. Plasma concentrations of bone turnover markers [ Time Frame: Week 4 ]
    Plasma levels of bone-specific alkaline phosphatase, osteocalcin, procollagen type I N-terminal propeptide (P1NP), C-terminal telopeptide (CTX), sclerostin and fibroblast growth factor 23 (FGF-23)

  7. Exome sequencing [ Time Frame: 24 hours ]
    Genetic variants of importance to vitamin D metabolism

  8. Plasma concentrations of total cholesterol, triglycerides, LDL- and HDL-cholesterol [ Time Frame: 24 hours ]
    Cholesterol status

  9. Plasma concentrations of metabolites [ Time Frame: 24 hours ]
    Metabolomics analyses: Blood samples for nuclear magnetic resonance and liquid chromatography mass spectrometry analyses

  10. General health [ Time Frame: Week 1 ]
    Questionnaire

  11. Dietary habits [ Time Frame: Week 1 ]
    Questionnaire

  12. Sun exposure [ Time Frame: Week 1 ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal
  • Caucasian
  • Total plasma 25-hydroxy vitamin D < 50 nmol/L
  • Understand oral and written Danish
  • Able to consent

Exclusion Criteria:

  • Known allergic reaction/intolerance to Vitamin D supplementation / milk products / juice
  • Known chronic kidney disease (creatinine > 90 µmol/L), previous kidney transplantation or known kidney artery stenosis
  • Known liver disease
  • Known gastrointestinal malabsorption
  • Current malignant disease
  • Hypercalcemia (ionised calcium ≥ 1.33 mmol/L)
  • Treatment with diuretics, lithium or current use of steroids
  • Current use of calcium and/or vitamin D supplementation
  • Planned travel during the intervention period to areas where sun exposure is expected
  • Use of solarium
  • Treatment with beta-blockers
  • Overt cardiovascular disease such as known severe heart failure (NYHA III-IV), previous major heart surgery, pacemaker, arrhythmias (e.g. atrial fibrillations or flutter, second- and third-degree atrioventricular block)

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): NCT03783273


Locations
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Denmark
Dept. of Endocrinology and Internal Medicine, The Osteoporosis Clinic Recruiting
Aarhus N, Denmark, 8200
Contact: Rasmus Espersen, MD    +45 28264034    auh.dfort@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Lars Rejnmark Dept. of Endocrinology and Internal Medince, The Osteoporosis Clinic

Publications:
Kazmi SA, Vieth R, Rousseau D. Vitamin D3 fortification and quantification in processed dairy products. International Dairy Journal 17:753-759, 2007

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03783273     History of Changes
Other Study ID Numbers: 1107213017
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Vitamin D Insufficiency
Vitamin D Supplementation
Food Fortification
Additional relevant MeSH terms:
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Calcium-Regulating Hormones and Agents
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents