Effect of vitaminD3 or 25(OH)D3 Fortified Dairy on Vitmain D Status and CVD Risk Markers

University of Reading

Status: Unknown

Conditions: Cardiovascular Diseases; Hypovitaminosis D

Treatments: Dietary Supplement: Control; Dietary Supplement: vitamin D3; Dietary Supplement: 25(OH) D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02535910

VitD

Details and patient eligibility

About

This study aims to compare the acute effect of consuming milk and butter fortified with either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and cognitive function will be examined.

Full description

There is mounting evidence to show that vitamin D deficiency may increase the risk of many common and serious diseases, including osteoporosis, cardiovascular disease, some cancers and type 1 diabetes (Holick and Chen, 2008). Hypovitaminosis D is now prevalent in the UK general population. Due to diet and lifestyle changes and the use of sun block products most people do not endogenously synthesise sufficient vitamin D from sunlight exposure (Hyppönen and Power, 2007). Therefore, vitamin D intakes from dietary sources have become very important, however this is limited as there are only a few foods naturally rich in vitamin D.

Some countries (e.g. USA, Canada) fortify milk with vitamin D which results in milk being the major contributor to vitamin D intake. Vitamin D3 is the most common form used for the fortification of currently fortified foods. However, there is now some evidence that 25(OH)D3 can increase vitamin D status of humans more effectively than vitamin D3 (Bischoff-Ferrari et al, 2012; Cashman et al, 2012). To our knowledge, very few human intervention studies have compared the efficacy of 25(OH)D3 versus vitamin D3 to increase vitamin D status, and there has been no acute human study to examine the effect of the both forms of vitamin D fortified dairy products on vitamin D status in humans.

Enrollment: 18 estimated patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI: 20-35 kg/m2
• Glucose <7 mmol/l (not diagnosed with diabetes)
• Total cholesterol <7 mmol/l
• TAG <4 mmol/l
• Serum 25(OH)D3 ≤50 nmol/L
• Normal liver and kidney function
• Haemoglobin: adult male >125 g/L

Exclusion criteria

• Milk allergy/intolerance or lactose intolerance
• Cardiovascular, renal, gastrointestinal, respiratory, endocrine disease or cancer
• Use of nutritional supplements, particularly those containing vitamin D
• Outdoor workers and use of tanning beds
• Overseas holidays two months before or during study period

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 3 patient groups, including a placebo group

breakfast rich in vitamin D3

Experimental group

Description:

subjects are asked to consume a breakfast with (20µg) vitamin D3 fortified milk and butter

Treatment:

Dietary Supplement: vitamin D3

breakfast rich in 25(OH) D3

Experimental group

Description:

subjects are asked to consume a breakfast with (20µg) 25(OH) D3 fortified milk and butter

Treatment:

Dietary Supplement: 25(OH) D3

Control

Placebo Comparator group

Description:

subjects are asked to consume a normal milk and butter (no vitamin D is added) in the breakfast

Treatment:

Dietary Supplement: Control