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

Hypovitaminosis D Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543671
• Other study ID #: 613977
• Status: Completed
• Phase: N/A
• First received: September 3, 2015
• Last updated: September 4, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bioethics Committee of Harokopio University: Greece
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avitaminosis
• Deficiency of Micronutrients
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

Other:
• vitamin D3 enriched, reduced-fat yellow cheese
60 grams of vitamin D3 enriched, reduced-fat yellow cheese provide 5.7 micrograms of vitamin D per day for 8 weeks
• plain (non-fortified) reduced-fat yellow cheese
60 grams of plain (non-fortified), reduced-fat yellow cheese provide 0 micrograms of vitamin D per day for 8 weeks

Locations

Country	Name	City	State
Greece	Harokopio University of Athens	Kallithea	Attica

Sponsors (3)

Lead Sponsor	Collaborator
Harokopio University	FrieslandCampina, University College Cork

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25-hydroxyvitamin D concentration		8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No