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Trial record 64 of 123 for:    hypertension "vitamin d"

The Trinity, Ulster and Department of Agriculture Cohort Study (TUDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02664584
Recruitment Status : Unknown
Verified January 2016 by University of Ulster.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2016
Last Update Posted : January 27, 2016
University of Dublin, Trinity College
University College Cork
University College Dublin
Information provided by (Responsible Party):
University of Ulster

Brief Summary:


Cardiovascular disease (CVD), osteoporosis and dementia are chronic diseases of ageing that impact adversely on the lives of those affected and have major health, social and economic consequences. A number of factors are considered to be implicated in these diseases, ranging from the more established factors to those that are less well recognised. Lifestyle factors such as diet, body weight, smoking, physical activity and years of education are acknowledged as risk factors for the development of these chronic diseases of aging. Emerging research suggests that elevated homocysteine and/or sub-optimal status of the metabolically related B-vitamins (folate, vitamin B12, B6 and riboflavin) may be associated with a higher risk of age-related disease. The interplay between relevant genetic and nutrient factors (gene-nutrient interactions) is considered to be highly relevant in the development (and prevention) of chronic diseases of ageing, however this relatively new area of research is as yet poorly understood. The collection of clinical, lifestyle, nutritional and genetic data on large numbers of patients would permit the investigation of those nutrients which interact with specific genes to increase the likelihood of a person developing chronic diseases of ageing.


The aim of the TUDA study is to collect detailed clinical, lifestyle, dietary, genetic and biochemical data to investigate gene-nutrient interactions (particularly from the perspective of the B-vitamins and vitamin D/calcium) in the development of CVD, osteoporosis and dementia by studying older adults exhibiting the early stages of these common diseases, namely hypertension, low bone mineral density, and early memory loss, respectively.

Secondary aim (follow up TUDA investigation):

The aim of this longitudinal investigation is to re-assess clinical, nutritional, genetic and biochemical factors in relation to the progression of disease outcomes in TUDA study participants, in subsequent years after initial investigation.

Study design:

A total of 6000 non-institutionalised older Irish people aged over 60 years with early predictors of either dementia, stroke and osteoporosis (namely early memory loss, high blood pressure and low bone mineral density, respectively) recruited from three centres (St James's Hospital Dublin, Ulster University Coleraine and The Clinical Translational Research and Innovation Centre (C-TRIC), Londonderry) across Ireland. Non-fasting blood samples were collected from all subjects and routine blood biochemistry profiles and biomarkers of relevance to B vitamin and vitamin D status were measured. Supplement use was recorded and a targeted food frequency questionnaire was used to record dietary intakes of specific vitamins of interest (folate, B12, B6, riboflavin and D) from major food sources, particularly fortified foods. Physiological function tests including blood pressure, bone health (DXA scans) and cognitive function tests and anthropometric measures were also taken.

Condition or disease
Cardiovascular Disease Osteoporosis Alzheimer's Disease Hypertension

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Study Type : Observational
Actual Enrollment : 5186 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : December 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Cross-sectional cohort
Cohort who took part in the cross-sectional study (n=5186)
Cross-sectional cohort + follow-up
Cohort who took part in both the cross-sectional and follow-up study (planned n=500 (on-going))

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 10 years ]
  2. Bone health (DXA) [ Time Frame: 10 years ]
    Dual energy x ray absorptiometry (DXA) scan

  3. Cognitive function 1 (MMSE) [ Time Frame: 10 years ]
    Mini-Mental State Examination (MMSE)

  4. Cognitive function 2 (FAB) [ Time Frame: 10 years ]
    Frontal Assessment Battery (FAB)

  5. Cognitive function 3 (RBANS) [ Time Frame: 10 years ]
    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  6. Anxiety (HADS) [ Time Frame: 10 years ]
    Hospital Anxiety and Depression Scale (HADS)

  7. Depression (CES-D) [ Time Frame: 10 years ]
    Center for Epidemiologic Studies Depression Scale (CES-D)

Secondary Outcome Measures :
  1. Weight [ Time Frame: 10 years ]
  2. Routine biochemical markers [ Time Frame: 10 years ]
    Measured in blood

  3. Vitamin biomarkers [ Time Frame: 10 years ]
    Measured in blood

  4. Single nucleotide polymorphisms [ Time Frame: 10 years ]
    Measured in DNA sample

  5. Measures of mobility (TUG) [ Time Frame: 10 years ]
    Timed Up and Go (TUG)

  6. Measures of muscle strength [ Time Frame: 10 years ]
    Hand grip strength (dynamometer)

  7. Bone turnover markers [ Time Frame: 10 years ]
    Measured in blood

Biospecimen Retention:   Samples With DNA
Blood samples Buccal swabs Buffy coats

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 60 and above

Inclusion Criteria:

  • >60 years of age

Exclusion Criteria:

  • <60 years of age
  • Born outside the island of Ireland
  • Severe dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02664584

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St James's Hospital
Dublin, Dublin8, Ireland
United Kingdom
Human Intervention Studies Unit, Ulster University
Coleraine, Londonderry, United Kingdom, BT52 1SA
Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
Londonderry, United Kingdom, BT47 6SB
Sponsors and Collaborators
University of Ulster
University of Dublin, Trinity College
University College Cork
University College Dublin

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Responsible Party: University of Ulster Identifier: NCT02664584     History of Changes
Other Study ID Numbers: 08NIR03/113
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Alzheimer Disease
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases