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Completed

NCT Number: NCT02543671

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

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.

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Key information

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harokopio University of Athens

Kallithea, Attica, 17671, Greece

About this study

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. .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D3 enriched, reduced-fat yellow cheese

Other

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

Other

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

Primary outcomes

  1. serum 25-hydroxyvitamin D concentration

    Time frame: 8 weeks

Secondary outcomes

  1. physical functioning scale, Short Form 36 health survey questionnaire (SF-36)

    Time frame: 8 weeks

    score range from 0 [worst disability related to physical functioning] to 100 [no disability related to physical functioning]

  2. role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)

    Time frame: 8 weeks

    score range from 0 [worst disability related to limitations due to physical health] to 100 [no disability related to limitations due to physical health]

  3. role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)

    Time frame: 8 weeks

    score range from 0 [worst disability related to limitations due to emotional problems] to 100 [no disability related to limitations due to emotional problems]

  4. vitality scale, Short Form 36 health survey questionnaire (SF-36)

    Time frame: 8 weeks

    score range from 0 [worst disability related to vitality to 100 [no disability related to vitality]

  5. emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)

    Time frame: 8 weeks

    score range from 0 [worst disability related to emotional well-being to 100 [no disability related to emotional well-being]

  6. social functioning scale, Short Form 36 health survey questionnaire (SF-36)

    Time frame: 8 weeks

    score range from 0 [worst disability related to social functioning to 100 [no disability related to social functioning]

  7. bodily pain scale, Short Form 36 health survey questionnaire (SF-36)

    Time frame: 8 weeks

    score range from 0 [worst disability related to bodily pain] to 100 [no disability related to bodily pain]

  8. general health scale, Short Form 36 health survey questionnaire (SF-36)

    Time frame: 8 weeks

    score range from 0 [worst general health] to 100 [best general health]

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • FrieslandCampina
  • University College Cork

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2015
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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