RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, - DOC 1 by HC120527113115

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									     RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
              KARNATAKA, BANGALORE
                              ANNEXURE- II


     REGISTRATION OF SUBJECT FOR DISSERTATION

1    NAME OF THE CANDIDATE                   :           DR. ASHOK KRISHNA V S
                   ADDRESS                   :           DEPARTMENT OF
                                                         PHARMACOLOGY
                                                         SRI DEVARAJ URS MEDICAL
                                                         COLLEGE, KOLAR.


2    NAME OF THE INSTITUTION                  :           SRI DEVARAJ URS MEDICAL
                                                          COLLEGE
                                                          TAMAKA, KOLAR.


3    COURSE OF STUDY & SUBJECT                   :        M.D PHARMACOLOGY


4    DATE OF ADMISSION TO COURSE :                        31-05-2007


5    TITLE OF THE TOPIC        COMPARATIVE STUDY OF
                                                 :
     EFFICACY AND SAFETY OF IRON POLYMALTOSE COMPLEX
     VERSUS SODIUM FEREDETATE IN IRON DEFECIENCY
     ANAEMIA

6.   BRIEF RESUME OF THE INTENDED WORK:

     6.1 Need for the study:
        Iron deficiency anaemia is a common problem in Indian population especially due to
     dietary deficiency (most common), increased requirement during pregnancy, lactation
     and growth spurt, blood loss due to menstrual disorders and hook worm infestation.1 So,
     oral supplementation with iron preparations is frequently required. Various iron
     preparations are available in the market with different elemental iron content, but their
     extent of absorption and bioavailability is variable. The gastrointestinal side effects differ
     in the severity leading to poor patient compliance. Attempts have been made to
     overcome the above problems and also improve patient compliance by making complex
     iron preparations like iron polymaltose complex and iron chelation with EDTA (sodium
     feredetate) which are claimed to have better bioavailability, less food interaction and
    good gastrointestinal tolerance.2,3,4,5
        As definite comparative studies are lacking with the above two compounds to
    substantiate their claim to be better iron preparations, the present study has been taken up
    in patients of Kolar district.


    6.2 Review of literature:
            The preferred practice for the management of iron deficiency anaemia has been
    oral administration of one of the ferrous preparations like ferrous sulphate, ferrous
    fumarate, ferrous gluconate which are no doubt cost effective and produce good
    improvement but have certain limitations like varying elemental iron content, differing
    bioavailability, interactions with food and gastrointestinal intolerance like gastric
    irritation, constipation and diarrhea which may result in poor patient compliance.
    Moreover, they are dangerous in acute overdosage.2
        Iron polymaltose complex is a non-ionic ferric iron bound to polymaltose forming a
    stable complex. It is claimed to have less gastrointestinal irritation, better bioavailability,
    less interaction with food and less dangerous in case of over dosage. Few studies have
    shown that it has high efficacy in patients with iron deficiency anaemia including
    pregnant women.2,6,7
        The other preparation, sodium feredetate, is an iron chelate of ethylene diamine tetra
    acetate (EDTA). The iron remains complexed with EDTA under acidic conditions and is
    released in upper small intestine for absorption. It has been claimed that absorption of
    sodium feredetate is almost twice as that of ferrous sulphate with less gastrointestinal
    side effects.3,4,5


    6.3 Objectives of study:
        A. To study the effectiveness of iron polymaltose complex in comparison with that
            of sodium feredetate in iron deficiency anaemia
        B. To asses the side effect profile of iron hydroxide polymaltose complex and
            sodium feredetate
7   MATERIALS AND METHODS:

    7.1 Source of data(sample):
           The study will be conducted on both inpatients and out patients attending the
    general medicine department of R.L.Jalappa Hospital and Research centre attached to Sri
    Devraj Urs Medical College, Tamaka, Kolar, Karnataka for a period of one and a half
    year from1-12-2007 to 30-05-2009.
 Inclusion Criteria:

   1. Male and female patients under the age group of 19 to 60 years
   2. Patients having microcytic hypochromic anaemia due to iron deficiency
   3. Patients with haemoglobin levels between 6g/dl and 10g/dl

 Exclusion Criteria:

   1. Anaemia due to acute haemorrhage
   2. Patients who have undergone resective gastric and small intestinal surgery
   3. Patients having anaemia due to bleeding disorders
   4. Known case of renal and hepatic failure
   5. Patients who have received iron therapy within last two months
   6. Patients with history of peptic ulcer, ulcerative colitis and bleeding piles
   7. Known case of malignancy
   8. Pregnant and lactating mothers
     .

7.2 Method of collection of data:
    60 patients with either sex will be included in the study and will be divided into 2
groups of 30 patients each. Informed consent will be taken from the patient before the
commencement of administration of the iron preparation in the prescribed informed
consent form. Detailed clinical examination and necessary investigations will be done
before starting the therapy. Consecutive patients will receive either iron polymaltose
complex or sodium feredetate in the dose of 100mg elemental iron per day, for a period
of two months. The patients will be evaluated on day 0, 30, 60, for clinical,
hematological and biochemical improvement and also monitored for side effects.
   The response to treatment will be analyzed by noting the reticulocyte count, mean
hemoglobin level changes, serum iron, total iron binding capacity, changes in the
peripheral blood picture and by evaluation of symptoms using composite score of
physical well being and clinical signs. 3,8 The results within the group will be analyzed
using paired student ‘T’ test and between the groups using unpaired student ‘T’ test.
7.3 Does the study require any investigations or interventions to be conducted on
   patients or other humans or animals? If so, please describe briefly.
   Yes. The study requires the following investigations.
1. Hemoglobin level
2. Peripheral blood picture
3. Reticulocyte count
     4. Serum iron and total iron binding capacity
     5. Stool examination for cysts, ova and occult blood
     6. Urine microscopy, albumin and sugar


     7.4 Has ethical clearance been obtained from your institution in case of 7.3?

              Yes, the ethical clearance has been obtained from the ethical clearance

     committee of Sri Devaraj Urs Medical College, Kolar.


8.   LIST OF REFERENCES:
     1. Mehta BC. Iron deficiency anaemia. In: Shah SN, Anand MP editors. API Textbook of
       Medicine. 7th edn. Mumbai: The Association of Physicians of India 2003: 930-939.
     2. Reddy PS, Adsul BB, Gandewar K, Desai A. Mumfer (iron polymaltose complex) in
       the management of anaemia in pregnancy- An Indian study. J Indian Med Assoc.
       2003; 98(6): 343-346.
     3.Sarkate P, Patil A, Parulekar S, Rege NN, Samant, Lokhande J, et al. A randomized
      double-blind study comparing sodium feredetate with ferrous fumerate in anaemia in
      pregnancy. J Indian Med Assoc. 2007; 105(3): 272-282.
     4. Liovera D, Ramirez J, Leets I, Tropper E. Iron bioavailability in humans from
       breakfastenriched with iron bis-glycine chelate, phytates and polyphenols. Journal of
       Nutrition. 2000; 130: 2145-2199.
     5. Mendoza C, Viteri FE, Lonnerdal B, Raboy V, Young KA, Brown KH. Absorption of
       iron from unmodified maize and genetically altered, low-phytate maize fortified with
       ferrous sulphate or sodium iron EDTA. Am. J. Clin. Nutr. 2001; (1)73: 80-85.
     6. Saha L, Pandhi P, Gopalan S, Saha PK. Comparison of efficacy, tolerability and cost
       of iron polymaltose complex with ferrous sulphate in the treatment of iron deficiency
       anaemia in pregnant women. MedGenMed.2007; 9(1): 1.
     7. Bhandwar VR, Rao S, Fonseca MM. Comparative efficacy and safety of iron
       polymaltose complex and ferrous fumarate in the treatment of adult patients with iron
      deficiency anaemia. Indian Medical Gazette. 2003; 136: 296-301.
     8. Adsul BB, Desai A, Gawde A, Baliga V. Comparative assessment of the
       bioavailability, efficacy and safety of a Modified – Release (MR) carbonyl iron tablet
       and oral conventional iron preparation in adult Indian patients with nutritional iron
       deficiency anaemia. J Indian Med Assoc. 2005; 103(6): 338-342.
9.    SIGNATURE OF THE CANDIDATE :

10.   REMARKS OF THE GUIDE: Iron deficiency anaemia is a major health problem in
      India. The present study will help us to find out the efficacy, compliance and safety
      profile of the two ferric iron preparations. These two preparations contain iron
      complexed with polymaltose and EDTA and are claimed to be better tolerated apart from
      being efficacious. The present study will help to ascertain whether the claims made can
      be substantiated.

11.   NAME AND DESIGNATION OF
       (in block letters)

      11.1) Guide                      : DR. SARALA N M.D
                                         ASSOCIATE PROFESSOR,
                                         DEPARTMENT OF PHARMACOLOGY,
                                         S.D.U.M.C, KOLAR




      11.2) Signature



      11.3) Co-Guide                    : DR. VENKATARATHNAMMA P N                M.D.
                                          PROFESSOR,
                                          DEPARTMENT OF MEDICINE,
                                          S.D.U.M.C, KOLAR




      11.4) Signature


      11.5) Head of Department          : DR. KUMAR T N M.D.
                                          PROFESSOR & H.O.D,
                                          DEPARTMENT OF PHARMACOLOGY,
                                          S.D.U.M.C, KOLAR

      11.6) Signature
12.   12.1) Remarks of Chairman and Principal




      12.2) Signature
RAJIV GANDHI UNIVERSITY OF HEALTH
       SCIENCES, KARNATAKA
           BANGALORE.




       M.D (PHARMACOLOGY)



 SRI DEVARAJ URS MEDICAL COLLEGE,
       TAMAKA, KOLAR -563 101


 COMPARATIVE STUDY OF EFFICACY AND
SAFETY OF IRON POLYMALTOSE COMPLEX
  VERSUS SODIUM FEREDETATE IN IRON
        DEFICIENCY ANAEMIA


                 BY:
        DR. ASHOK KRISHNA V S
  SRI DEVARAJ URS MEDICAL COLLEGE,
        TAMAKA, KOLAR -563101
                                     PROFORMA



I. 1. Name                                           6. OP/IP
   2. Age                                            7. Hospital no.
   3. Sex                                            8. D.O.A             D.O.D
   4. Address:


 5. Contact no.

II. Presenting complaints with duration




III. History of presenting illness




IV. Past history – H/o bleeding / worm infestation


V. Obstetric history

VI. Menstrual history

VII. Family and socio economic history

VIII. Personal history – Diet – Vegetarian / Non vegetarian

IX. General Physical Examination

   1. Vital signs: Pulse             , BP            , RR

   2. Pallor            Icterus      Cyanosis                  Clubbing
      Edema             Nail changes

   3. Weight            Height       Built

X. Any specific clinical findings of iron deficiency anaemia
   1. Angular stomatitis
   2. Painless glossitis
   3. Dysphagia due to pharyngeal web
   4. Koilonychia
   5. Cheilosis
XI. Systemic examination

    1. Cardiovascular examination




    2. Respiratory examination




    3. Abdominal examination




    4. CNS examination




XII. Investigations at the first visit

    1.   Hb
    2.   Peripheral blood picture
    3.   Reticulocyte count
    4.   Serum iron
    5.   TIBC
    6.   Stool examination for cysts, ova and occult blood
    7.   Urine microscopy, albumin and sugar




XIII. Treatment given
                                   Follow up

                              Day 0               Day 30               Day 60
Composite score of
physical well being*
Fatigue
Malaise
Loss of appetite
Breathlessness
Palpitations
Giddiness
Irritability
Reduced work
performance
Total score
Pallor (Present/Absent)
Investigations
Hb
Peripheral blood smear
Reticulocyte count
Serum Iron
TIBC
Adverse effects**
(Mild/Moderate/Severe)
Nausea
Heartburn
Epigastric pain
Diarrhoea
Constipation
Headache
Rash
Any others
Compliance
(present/absent)


*
0            Nil              No occurrence of symptoms
1            Mild             Symptom present but not troublesome
2            Moderate         Annoying and disturbing daily activities
3            Severe           Continuously present, interferes with daily activities

Maximum score = 24               Minimum score = 0

**
Mild                  Discomfort but tolerable
Moderate              Discomfort and required treatment
Severe                Required stopping iron supplement

								
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