Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study.

Detailed Description
-----------------
Vitamin D status in postmenopausal women is of interest because of the association of low vitamin D status with increased risk of osteoporosis and related fractures. In addition, since there is increasing evidence that the dietary supply is often insufficient to offset the seasonal deficit in sunlight during winter months, fortified food and supplements are becoming important sources of dietary vitamin D intake to achieve optimal vitamin D status, especially in this high risk population. Although most studies have examined the effectiveness of vitamin D enriched milk and yogurt, there have been limited studies also exploring the effectiveness of vitamin D enriched cheese in enhancing vitamin D status and preventing vitamin D deficiency. However, fortification of cheese with vitamin D has certain technological considerations, particularly for reduced-fat varieties considering that vitamin D is a fat soluble nutrient. The primary aim of the current study was to investigate whether the consumption of vitamin D3 enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum 25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in what degree it can contribute as a potential food-based strategy for the prevention of vitamin D deficiency. A secondary aim was also to investigate any potential effect of the intervention in several quality of life (QoL) indices in the population of postmenopausal women under study. .

Official Title
-----------------
Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency

Conditions
-----------------
Hypovitaminosis D, Deficiency of Micronutrients

Intervention / Treatment
-----------------
* Other: vitamin D3 enriched, reduced-fat yellow cheese
* Other: plain (non-fortified) reduced-fat yellow cheese


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects are eligible if they are 55-75 years of age being at menopause for more than 5 years they used to consume cheese daily those with a Body Mass Index (BMI) range 20-33kg/m2 Exclusion Criteria: having any disease/ pathology that interacts with vitamin D metabolism taking medications that interact with vitamin D metabolism or vitamin D supplements for medical reasons (e.g. osteoporosis) planned vacation to a sunny holiday destination during the intervention period having a cow's milk allergy having a drugs and/or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin D3 enriched cheese<br>vitamin D3 enriched, reduced-fat yellow cheese | Other: vitamin D3 enriched, reduced-fat yellow cheese<br>* 60 grams of vitamin D3 enriched, reduced-fat yellow cheese provide 5.7 micrograms of vitamin D per day for 8 weeks<br>|
| Placebo Comparator: plain cheese<br>plain (non-fortified) reduced-fat yellow cheese | Other: plain (non-fortified) reduced-fat yellow cheese<br>* 60 grams of plain (non-fortified), reduced-fat yellow cheese provide 0 micrograms of vitamin D per day for 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25-hydroxyvitamin D concentration |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical functioning scale, Short Form 36 health survey questionnaire (SF-36) | score range from 0 [worst disability related to physical functioning] to 100 [no disability related to physical functioning] | 8 weeks | 
| role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36) | score range from 0 [worst disability related to limitations due to physical health] to 100 [no disability related to limitations due to physical health] | 8 weeks | 
| role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36) | score range from 0 [worst disability related to limitations due to emotional problems] to 100 [no disability related to limitations due to emotional problems] | 8 weeks | 
| vitality scale, Short Form 36 health survey questionnaire (SF-36) | score range from 0 [worst disability related to vitality to 100 [no disability related to vitality] | 8 weeks | 
| emotional well-being scale, Short Form 36 health survey questionnaire (SF-36) | score range from 0 [worst disability related to emotional well-being to 100 [no disability related to emotional well-being] | 8 weeks | 
| social functioning scale, Short Form 36 health survey questionnaire (SF-36) | score range from 0 [worst disability related to social functioning to 100 [no disability related to social functioning] | 8 weeks | 
| bodily pain scale, Short Form 36 health survey questionnaire (SF-36) | score range from 0 [worst disability related to bodily pain] to 100 [no disability related to bodily pain] | 8 weeks | 
| general health scale, Short Form 36 health survey questionnaire (SF-36) | score range from 0 [worst general health] to 100 [best general health] | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D status, 25-hydroxyvitamin D, cheese, Randomized controlled trial, postmenopausal women, enriched, vitamin D3