ANNEXURE- II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS
(IN BLOCK LETTERS) / DR. PRASHANT HUBBALLI
PG. IN GENERAL MEDECINE,
KARNATAKA INSSTITUTE OF
MEDICAL SCIENCES,
HUBLI-580022.
2. / NAME OF THE INSTITUTION / KARNATAKA INSTITUTE OF
MEDICAL SCIENCES,HUBLI-22.
3. / COURSE OF STUDY AND SUBJECT / M.D. IN GENERAL MEDICINE.
4. / DATE OF ADMISSION TO COURSE / 29-04-2010
5. / TITLE OF THE TOPIC / “STUDY OF SERUM CALCIUM IN ESSENTIAL HYPERTENSION”
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR STUDY
Hypertension is one of the leading causes of death and disability among adults all over the world. It remains the major risk factor for coronary, cerebral and peripheral vascular disease. Essential hypertension comprises more than 90% of hypertension. Hypertension is an emerging health problem in India. When majority of people come to know that they have hypertension they have already advanced into a stage with target organ damage - a fatal stroke or myocardial infarction or irreversible renal failure. In addition to a primary increase in cardiac function propelled by overactive sympathetic nervous system, primary retention of salt and water bykidney, other factors contributing to hypertension are hereditary predisposition and high Sodium and low Potassium intake and excretion.
In a country like India, people tend to have a diet rich in Sodium and poor in Potassium, and Calcium.Studies have shown that a decreased intake of Sodium and increased Calcium intake or both together may be effective in prevention or even treatment of hypertension.
6.2 REVIEW OF THE LITERATURE:
Roberta M. Rayet alof American Heart Association conducted a study on effect of Calcium and Vitamin D supplementation on Blood Pressure in the year 2008. In this study, participants were randomly assigned in a double-blind fashionto receive 1000 mg of elemental calcium plus 400 IU of vitaminD3 daily or placebo.Each active tablet provided 500 mg ofcalcium (as calcium carbonate) and 200 IU of vitamin D3. Participants were instructed to take 2tablets daily, preferably in divided doses with meals.BP was measured by certified staff using standardized proceduresand instruments, in the right arm, with a conventional mercurysphygmomanometer and an appropriately sized cuff, after theparticipant was seated and resting for 5 minutes.From baseline to the end of follow-up, systolic BP declinedby 1 mm Hg during follow-up, whereas diastolic BP declined by4 mm Hg.
Khashayar Sakhaee et al – conducted the NHANES I study. It was the first epidemiological survey which studied over 10,000 subjects linkingthe inverse relationship between serum Calcium and hypertension.
K.Sudhakaret al in 2004 studied serum calcium levels in 117 subjects with essential hypertension and 77 first-degree relatives.The results showed that serum calcium levels were significantly (p<0.01) decreased in both malesand females with essential hypertension and their first-degree relatives when compared with the normotensive controls.
Michael B. Zemel in 2001opined that regulation of intracellular calcium plays a key role in hypertensionand obesity.Dysregulation of calcium homeostasis appears tobe a fundamental factor linking these conditions. Regulationof intracellular calcium in key disease-related target tissuesby calcitrophic hormones provides the opportunity to modulatedisease risk with dietary Calcium.
Langford and Watson in 1987were the first one toreport the inverse relationship between serum calcium and hypertension.In a study of 100 black women they found that individuals with low SBP(105mmHg) has consumed more calcium than others with high SBP (125mmHg).This study showed that calcium may be a protective factor in hypertension.
AR Folsomet al in 1986studied the concentrations of serum total Calcium and serum Calcium fractions between 28 hypertensive subjects and 28 race-sex-age-matchednormotensive controls. Mean levels of serum total Calcium were notdifferent between the two groups. Hypertensive subjects had lower meanserum levels of ultrafilterable calcium (-0.32 mg/dl; p = 0.01), ionizedcalcium (-0.07 mg/dl; p = 0.09), and complexed calcium (-0.23 mg/dl; p =0.04) and higher levels of protein-bound calcium (+0.36 mg/dl; p = 0.07).Estimated dietary Calcium intake was similar in the two groups. Thesefindings add to the evidence that essential hypertension is associated withperturbations in calcium metabolism.
6.3 AIMS AND OBJECTIVES OF THE STUDY:
- To study the levels of serum Calcium in patients with primary hypertension.
- To correlate the serum Calcium levels with blood pressure.
7.
8. / MATERIALS AND METHODS :
7.1 SOURCE OF DATA:
Patients visiting Medicineout patient andpatients admitted in the Medicine wards of,Karnataka Institute of Medical Sciences, Hubli during the period of 1st January 2011 to 31st December2011 will be taken for study considering the inclusion and exclusion criteria.
7.2 METHOD OF COLLECTION OF DATA:
Information will be collected through a pre-tested and structured proforma for each patient. Qualifying patients will be undergoing detailed history,clinical examination and laboratory investigations.
TYPE OF STUDY: Analytical study.
INCLUSION CRITERIA:
1.Patients with primary hypertension.
2. Patients whose age is above 18 years are included.
3. Both sexes are included.
EXCLUSION CRITERIA:
1.Patients below 18 years.
2. Patients with renal failure.
3. Pregnancy.
4. Patients with acute diarrhoeal diseases.
PARAMETERS USED:
After applying inclusion and exclusion criteria a randomly selected group of patients will undergo detailed history,clinical examination and following set of investigations.
•Urine Albumin,
•Urine Sugar,
•Blood Glucose,
•Urea,
•Serum Creatinine,
•ECG,
•Serum Calcium,
•Total protein,
•Albumin,
•USG abdomen (if indicated).
SAMPLE SIZE:
A total of 100 subjects of which 50 cases of essential hypertension satisfying inclusion and exclusion criteria visiting medicine OPD and admitted in IPD of KIMS HUBLI and 50 age and sex matched normotensive controls from 1st December 2010 to 30thNovember 2011 will be taken up for study.
STATISTICAL ANALYSIS:
The data will be analysed with appropriate statistical method.
7.3Does the study require any investigations or interventions to be conducted on patients or other humans or animals? (If so, please describe briefly)
YES,
•Urine Albumin,
•Urine Sugar,
•Blood Glucose,
•Urea,
•Serum Creatinine,
•ECG,
•Serum Calcium,
•Total protein,
•Albumin,
•USG abdomen (if indiacated).
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of 7.3?
Yes, ethical clearance has been obtained from the ethical committee KIMS HUBLI.
LIST OF REFERENCES:
- Roberta M. Ray; Linda Van Horn; JoAnn E. Manson; Matthew A. Allison; Henry R. Black; Shirley A. et al ;Effect of Calcium and Vitamin D supplementation on Blood Pressure –The Womans’ health initiative randomized trial, American Heart Association:2008. 847-855.
- Khashayar Sakhaee and Naim M.Maalouf; Dietary Calcium, Obesity and Hypertension—The End of the Road?-The Journal of Clinical Endocrinology and Metabolism Vol 90,NO 7 4411-4413,2005.
- K.Sudhakar,M.Sujatha,S.Ramesh Babu,P.Padmavathi and P.P.Reddy; Serum Calcium levels in Essential Hyperetensives and their first degree relatives-Indain Journal of Clinical Bio Chemistry,2004,19(1) 21-23.
- Michael B.Zemel; Calcium Modulation and Obesity;Mechanism and ImplicationsJournal of the American College of Nutrition, Vol. 20, No. 90005 (2001), 428S-435S.
- Watson and Langford; Dietary calcium and hypertension: population studies- European Heart Journal 1987 (supplement B), 31-35.
- A R Folsom,CL Smith, RJ Prineas and RH Grimm Jr;Serum calcium fractions in essential hypertensive and matched normotensive subjects- American Heart Association,1986 Vol 8, 11-15
9. / Signature of the candidate
10. / Remarks of the guide / Recommended
11. / Name and Designation
11.1 Guide / DR. UDAY BANDE. M.D.
ASSOCIATE PROFESSOR,
DEPARTMENT OF MEDICINE
KIMS, HUBLI.
11.2 Signature
11.5 Head of the Department / DR. H. MALLIKARJUN SWAMY. M.D.
PROFESSOR AND HEAD,
DEPARTMENT OF MEDICINE
KIMS, HUBLI.
11.6 Signature
12. / 12.1 Remarks of the Principal and Chairman
12.2 Signature