Hypovitaminosis DNCT02543671
Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency
A study testing vitamin D3 enriched, reduced-fat yellow cheese and plain (non-fortified) reduced-fat yellow cheese in people with Hypovitaminosis D and Deficiency of Micronutrients, run by Harokopio University at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis D, Deficiency of Micronutrients
- What is being tested?
- vitamin D3 enriched, reduced-fat yellow cheese and plain (non-fortified) reduced-fat yellow cheese
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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. .
- Conditions
- Hypovitaminosis D, Deficiency of Micronutrients
- Being tested
- vitamin D3 enriched, reduced-fat yellow cheese, plain (non-fortified) reduced-fat yellow cheese
- Keywords
- vitamin D status, 25-hydroxyvitamin D, cheese, Randomized controlled trial, postmenopausal women, enriched, vitamin D3
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3 enriched, reduced-fat yellow cheeseOther
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 cheeseOther
60 grams of plain (non-fortified), reduced-fat yellow cheese provide 0 micrograms of vitamin D per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 enriched cheese | Active comparator | vitamin D3 enriched, reduced-fat yellow cheese Receives: Other: vitamin D3 enriched, reduced-fat yellow cheese |
| plain cheese | Placebo comparator | plain (non-fortified) reduced-fat yellow cheese Receives: Other: plain (non-fortified) reduced-fat yellow cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25-hydroxyvitamin D concentration
Measured: 8 weeks
Secondary outcomes (8)
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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, FrieslandCampina
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
- Investigators
- Yannis Manios, Associate Professor, Principal investigator, Harokopio University, Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543671
- Sponsor's protocol ID
- 613977
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT02543671
- Acronym / sponsor ID
- 613977
- Conditions
- Hypovitaminosis D, Deficiency of Micronutrients
- Keywords
- vitamin D status, 25-hydroxyvitamin D, cheese, Randomized controlled trial, postmenopausal women, enriched, vitamin D3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- University College Cork, FrieslandCampina
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 enriched cheese | Active comparator | Other: vitamin D3 enriched, reduced-fat yellow cheesevitamin D3 enriched, reduced-fat yellow cheese |
| plain cheese | Placebo comparator | Other: plain (non-fortified) reduced-fat yellow cheeseplain (non-fortified) reduced-fat yellow cheese |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D3 enriched, reduced-fat yellow cheese60 grams of vitamin D3 enriched, reduced-fat yellow cheese provide 5.7 micrograms of vitamin D per day for 8 weeks | Other | vitamin D3 enriched cheese |
| plain (non-fortified) reduced-fat yellow cheese60 grams of plain (non-fortified), reduced-fat yellow cheese provide 0 micrograms of vitamin D per day for 8 weeks | Other | plain cheese |
Primary outcome
serum 25-hydroxyvitamin D concentration
Time frame: 8 weeks
8 secondary outcomes
physical functioning scale, Short Form 36 health survey questionnaire (SF-36)
Time frame: 8 weeks
role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)
Time frame: 8 weeks
role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)
Time frame: 8 weeks
vitality scale, Short Form 36 health survey questionnaire (SF-36)
Time frame: 8 weeks
emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)
Time frame: 8 weeks
social functioning scale, Short Form 36 health survey questionnaire (SF-36)
Time frame: 8 weeks
bodily pain scale, Short Form 36 health survey questionnaire (SF-36)
Time frame: 8 weeks
general health scale, Short Form 36 health survey questionnaire (SF-36)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannis Manios, Associate Professor principal investigator
Harokopio University, Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 enriched, reduced-fat yellow cheese and plain (non-fortified) reduced-fat yellow cheese in people with Hypovitaminosis D and Deficiency of Micronutrients, run by Harokopio University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum 25-hydroxyvitamin D concentration (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.