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

NCT03783273 | Completed

• 1 other identifier: 1107213017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D Insufficiency; Vitamin D Supplementation; Food Fortification

Outcome Measures

Primary Outcomes (2)

• Cmax of vitamin D3

  Maximum observed concentration of vitamin D3

  10 hours

• AUC of vitamin D3

  Area under the curve for time-concentration relationships during the absorption phase

  12 hours

Secondary Outcomes (13)

• Concentration of vitamin D metabolites

  24 hours

• Concentration of PTH

  24 hours

• Plasma concentration of ion-calcium

  24 hours

• Urine concentration of calcium

  24 hours

• Urine concentration of creatinine

  24 hours

Other Outcomes (12)

• Body composition

  Week 4

• Areal BMD

  Week 4

• Bone geometry

  Week 4

Study Arms (5)

Whey protein complex-bound D3 + juice

EXPERIMENTAL

200 microgram vitamin D3 in a whey protein-complex added to 500 mL of juice.

Dietary Supplement: Vitamin D3; Combination Product: Whey protein-complex; Other: Juice

D3 + juice

ACTIVE COMPARATOR

200 microgram vitamin D3 added to 500 mL of juice.

Dietary Supplement: Vitamin D3; Other: Juice

D3 + milk

ACTIVE COMPARATOR

200 microgram vitamin D3 added to 500 mL of skimmed-milk.

Dietary Supplement: Vitamin D3; Other: Milk

D3 droplets

ACTIVE COMPARATOR

200 microgram vitamin D3 as droplets + 500 mL of water.

Dietary Supplement: Vitamin D3; Other: Water

No vitamin D

PLACEBO COMPARATOR

500 mL of Water.

Other: Water

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Single dose vitamin D3

D3 + juice; D3 + milk; D3 droplets; Whey protein complex-bound D3 + juice

Whey protein-complex COMBINATION_PRODUCT

Whey protein complex-bound vitamin D3

Whey protein complex-bound D3 + juice

Water OTHER

500 mL water

D3 droplets; No vitamin D

Milk OTHER

500 mL milk

D3 + milk

Juice OTHER

500 mL juice

D3 + juice; Whey protein complex-bound D3 + juice

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Dept. of Endocrinology and Internal Medicine, The Osteoporosis Clinic

Aarhus N, 8200, Denmark

Location

Related Publications (30)

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  BACKGROUND

• Cormick G, Ciapponi A, Cafferata ML, Belizan JM. Calcium supplementation for prevention of primary hypertension. Cochrane Database Syst Rev. 2015 Jun 30;2015(6):CD010037. doi: 10.1002/14651858.CD010037.pub2.

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• Billington EO, Bristow SM, Gamble GD, de Kwant JA, Stewart A, Mihov BV, Horne AM, Reid IR. Acute effects of calcium supplements on blood pressure: randomised, crossover trial in postmenopausal women. Osteoporos Int. 2017 Jan;28(1):119-125. doi: 10.1007/s00198-016-3744-y. Epub 2016 Aug 20.

  PMID: 27543500 BACKGROUND

• Van Bortel LM, Laurent S, Boutouyrie P, Chowienczyk P, Cruickshank JK, De Backer T, Filipovsky J, Huybrechts S, Mattace-Raso FU, Protogerou AD, Schillaci G, Segers P, Vermeersch S, Weber T; Artery Society; European Society of Hypertension Working Group on Vascular Structure and Function; European Network for Noninvasive Investigation of Large Arteries. Expert consensus document on the measurement of aortic stiffness in daily practice using carotid-femoral pulse wave velocity. J Hypertens. 2012 Mar;30(3):445-8. doi: 10.1097/HJH.0b013e32834fa8b0.

  PMID: 22278144 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Water; Milk

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Lars Rejnmark

  Dept. of Endocrinology and Internal Medince, The Osteoporosis Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if they receive juice with complex-bound vitamin D3 or not.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 21, 2018
• Study Start: January 8, 2019
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-02

Locations

DK (1)