Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02543671
Other study ID # 613977
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT05376865 - Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers N/A
Not yet recruiting NCT05214040 - Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients
Completed NCT02802449 - To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans N/A
Recruiting NCT00992797 - Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity Phase 2
Completed NCT00960232 - Vitamin D, Blood Pressure, Lipids, Infection and Depression Phase 3
Completed NCT01240213 - Vitamin D, Diet and Activity Study N/A
Completed NCT01793402 - Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants N/A
Completed NCT00887666 - Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure N/A
Completed NCT05425914 - Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level Phase 3
Not yet recruiting NCT04829487 - The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D N/A
Completed NCT05372224 - Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis N/A
Completed NCT02101151 - Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE) N/A
Completed NCT00695474 - Vitamin D and Type 2 Diabetes - a Cross Sectional Study N/A
Completed NCT02534714 - Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From July 1, 2015-June 30, 2016
Completed NCT02434380 - Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes Phase 3
Withdrawn NCT00944606 - Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children N/A
Recruiting NCT06138249 - Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels N/A
Completed NCT05346419 - Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients N/A
Completed NCT03381378 - Vitamin D and Hand Grip Strength at 5 Years in Odense Child Cohort N/A
Completed NCT02452762 - Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial Phase 2