Vitamin D Deficiency Clinical Trial
Official title:
Cross-sectional Study of the Association of Muscle Strength, Tinetti Test (POMA) Scores and Other Predictor Variables With Serum Vitamin Levels (Vitamin B12, Vitamin D and Folate) in Elderly Patients With Type 2 Diabetes Mellitus
Verified date | December 2017 |
Source | SingHealth Polyclinics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Vitamin B12 deficiency can cause severe problems with the blood, nerves, brain and
psychological well-being. Ironically, our modern methods for the control of diabetes mellitus
can actually contribute to vitamin B12 deficiency. This is because the diabetic medication
"metformin", low-cholesterol diets lacking in meats (a natural source of vitamin B12) and the
use of powerful anti-gastric medication can all reduce the natural absorption of vitamin B12
from the diet, especially in elderly people with diabetes.
There is both a high prevalence of vitamin B12 deficiencies and falls among the elderly with
type 2 diabetes mellitus and the investigators hypothesize that B12 deficiency contributes
directly and significantly to falls in elderly diabetics through impaired muscle strength,
gait and balance.
This study therefore proposes to investigate the association between vitamin B12 deficiency
and fall risk among diabetic elderly patients (older than 65 years) in the polyclinic setting
by assessing muscle strength, balance and walking speed. The predictors of vitamin B12,
folate, homocysteine and vitamin D levels will also be explored in this study.
If the hypothesis is right, this would be of public health importance & can lead to further
studies that can change the way we treat diabetes by reducing falls in our elderly diabetics
through the screening for, prevention and treatment of B12 deficiency.
Status | Completed |
Enrollment | 56 |
Est. completion date | August 31, 2014 |
Est. primary completion date | August 31, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: All Diabetic Adults > 65 years old who have been on follow-up at the Polyclinic for > 1 year; with Informed Consent. Exclusion Criteria: - Patients not fitting the Eligibility Criteria - Inability to walk despite assistive devices because of musculoskeletal disorders &/or - Acute or Terminal Illness &/or - Documented severe Disorders of the central nervous system (e.g. major stroke, Parkinson disease, dementia & severe visual impairment) however a subject with a previous history of stroke could be included provided he/she had recovered with no cognitive impairment or other residual effects that would affect the study results. - Inability to understand spoken questions &/or commands - Failure to give or withdrawal of Informed Consent - Patients not fitting the Eligibility Criteria - Patients who are part of the Family Physician Clinic (FPC), thus avoiding conflict of interest. |
Country | Name | City | State |
---|---|---|---|
Singapore | SingHealth Polyclinics - Marine Parade Polyclinic | Singapore |
Lead Sponsor | Collaborator |
---|---|
SingHealth Polyclinics |
Singapore,
Clarke R, Refsum H, Birks J, Evans JG, Johnston C, Sherliker P, Ueland PM, Schneede J, McPartlin J, Nexo E, Scott JM. Screening for vitamin B-12 and folate deficiency in older persons. Am J Clin Nutr. 2003 May;77(5):1241-7. — View Citation
de Jager J, Kooy A, Lehert P, Wulffelé MG, van der Kolk J, Bets D, Verburg J, Donker AJ, Stehouwer CD. Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial. BMJ. 2010 May 20;340:c2181. doi: 10.1136/bmj.c2181. — View Citation
Foo CL, Chan KC, Goh HK, Seow E. Profiling acute presenting symptoms of geriatric patients attending an urban hospital emergency department. Ann Acad Med Singapore. 2009 Jun;38(6):515-6. — View Citation
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation
Koh WP, Wang R, Ang LW, Heng D, Yuan JM, Yu MC. Diabetes and risk of hip fracture in the Singapore Chinese Health Study. Diabetes Care. 2010 Aug;33(8):1766-70. doi: 10.2337/dc10-0067. Epub 2010 May 26. — View Citation
Lin MR, Hwang HF, Hu MH, Wu HD, Wang YW, Huang FC. Psychometric comparisons of the timed up and go, one-leg stand, functional reach, and Tinetti balance measures in community-dwelling older people. J Am Geriatr Soc. 2004 Aug;52(8):1343-8. — View Citation
Lord SR, Menz HB, Tiedemann A. A physiological profile approach to falls risk assessment and prevention. Phys Ther. 2003 Mar;83(3):237-52. Review. — View Citation
Martin HJ, Yule V, Syddall HE, Dennison EM, Cooper C, Aihie Sayer A. Is hand-held dynamometry useful for the measurement of quadriceps strength in older people? A comparison with the gold standard Bodex dynamometry. Gerontology. 2006;52(3):154-9. — View Citation
Ministry of Health S. National Health Survey, 2010. Available at: https://www.moh.gov.sg/content/moh_web/home/Publications/Reports/2011/national_health_survey2010.html. Accessed 10 Sep 2017.
Ministry of Social and Family Development. National survey of senior citizens, 2005. Available at: https://www.msf.gov.sg/publications/Pages/National-Survey-on-Senior-Citizens-in-Singapore-2005.aspx. Accessed on 12 Dec 2017
Ng TP, Niti M, Chiam PC, Kua EH. Physical and cognitive domains of the Instrumental Activities of Daily Living: validation in a multiethnic population of Asian older adults. J Gerontol A Biol Sci Med Sci. 2006 Jul;61(7):726-35. — View Citation
Pflipsen MC, Oh RC, Saguil A, Seehusen DA, Seaquist D, Topolski R. The prevalence of vitamin B(12) deficiency in patients with type 2 diabetes: a cross-sectional study. J Am Board Fam Med. 2009 Sep-Oct;22(5):528-34. doi: 10.3122/jabfm.2009.05.090044. Erratum in: J Am Board Fam Med. 2010 Sep-Oct;23(5):695. Seaquist, D [added]. — View Citation
Sallinen J, Stenholm S, Rantanen T, Heliövaara M, Sainio P, Koskinen S. Hand-grip strength cut points to screen older persons at risk for mobility limitation. J Am Geriatr Soc. 2010 Sep;58(9):1721-6. doi: 10.1111/j.1532-5415.2010.03035.x. — View Citation
Skrabal F. Syncope, falls and cobalamin deficiency in the old population. Clin Auton Res. 2004 Apr;14(2):60-6. Review. — View Citation
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Wee AK. Serum folate predicts muscle strength: a pilot cross-sectional study of the association between serum vitamin levels and muscle strength and gait measures in patients >65 years old with diabetes mellitus in a primary care setting. Nutr J. 2016 Oct — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle strength (Hand-grip) | Hand-grip strength in kg force as measured by the JAMAR dynamometer . | At recruitment | |
Primary | Muscle strength (Leg extension) | Leg strength in kg force as measured by a leg dynamometer. | At recruitment | |
Secondary | Falls | Self-reported falls in the 12 months preceding the recruitment into the study | At recruitment | |
Secondary | Gait speed | Tinetti performance-oriented mobility assessment -Gait score (POMA G, Maximum score of 12) | At recruitment | |
Secondary | Gait speed | 6-metre gait speed (m/s) | At recruitment | |
Secondary | Gait speed | Timed-up-and-go test (s) | At recruitment | |
Secondary | Balance | Tinetti performance-oriented mobility assessment -Balance score (POMA B , Maximum score of 16) | At recruitment | |
Secondary | Neuropathy | Vibration perception threshold using a neurothesiometer (volts) | At recruitment | |
Secondary | Activity of daily living | Barthel index of activity of daily living (maximum score of 20) | At recruitment | |
Secondary | Instrumental Activity of daily living | Lawton instrumental activities o daily living (maximum score of 8) | At recruitment | |
Secondary | Vitamin B12 deficiency | serum vitamin B12 levels < 150pmol/L | At recruitment | |
Secondary | Folate deficiency | serum folate levels < 13.5 nmol/L | At recruitment | |
Secondary | Hyperhomocysteinemia | serum homocysteine = or > 15 umol/L | At recruitment | |
Secondary | Vitamin D deficiency | serum 25-OH vitamin D < 49.9 nmol/L | At recruitment |
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