Proforma for registration of subjects for dissertation

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION.

1. Name of the candidate and address: Dr. P.Vairavasolai,

115, Janaillam,

MR.K Street, Pallathur,

Sivaganga Dist,

Tamil Nadu-630107.
2. Name of the Institution: Kempegowda Institute of Medical Sciences,

Banashankari II stage,

Bangalore-560070.
3. Course of Study and Subject: M.D in Community Medicine
4. Date of Admission to Course: 6^th June 2013,
5. Title of the study: A study to assess the effectiveness of weekly versus daily oral iron and folic acid therapy among women in the reproductive age group residing in the urban field practice area of Kempegowda Institute Of Medical Sciences.

6. Brief resume of Intended Work:

6.1 Need for the study:

Anemia is one of the most common causes of malnutrition and it has a great public health significance affecting children, adolescents and women of reproductive age group.¹ WHO defines Anemia as“a condition in which the Haemoglobin content of blood is lower than normal as a result of deficiency of one or more essential nutrients, regardless of cause of such deficiency”.

Nutrition deficiencies are the most common cause of anemia and Iron deficiency anemia is a major contributor to the global burden of the disease.Iron deficiency adversely affects:

1. 
   The cognitive performance, behaviour and physical growth of infants, preschool and
   

school-age children.

b) The immune status and morbidity from infections of all age groups.

c) The use of energy sources by muscles and thus the physical capacity and work

performance of adolescents and adults of all age groups.

Iron deficiency anemia occurs as a result of decreased haemoglobin concentration in the blood and decreased iron concentrations, leading to iron deficiency.It is estimated that at least half the burden of anemia is due to iron deficiency and can be induced by sustained negative iron balance due to inadequate dietary intake, absorption and utilization of iron or chronic loss of iron due to bleeding.

It is a serious public-health concern in most developing countries^.2 It accounts for 12.8 % of maternal deaths in Asia.

The consequences of anaemia in women are enormous as the condition adversely affects

both their productive and reproductive capabilities. Among women of reproductive age group, adolescent girls and pregnant women are at most risk for anemia; adolescents because the body loses iron during menstruation and they usually do not compensate for that lose by eating more iron rich foods and pregnant women due to the increased demand for iron. National Family Health survey data III, shows that the prevalence of anemia among women of reproductive age group in India was 56.1%.³

In the World Health Organisation (WHO)/World Bank rankings, IDA is the third leading cause of DALYs(disablity adjusted life years) lost for females aged 15–44 years.^4,5

Haemoglobin estimation is the primary method of anemia diagnosis.In non-pregnant reproductive aged women, based on the concentration of haemoglobin in the blood, WHO classified anemia into three groups as Mild, Moderate, and Severe.⁶

Mild – 11- 11.9 g/dl

Moderate – 8- 10.9 g/dl

Severe -<8g/dl.
In communities where iron deficiency is highly prevalent, successful Iron supplementation results in the disappearance of anemia,except where malaria and HIV or hookworm infection rates are high. Daily oral iron folic acid is the standard recommended approach to treat anemia. Recently WHO recommended intermittent use of oral iron to prevent and control iron deficiency anemia as there is poor compliance and poor bowel absorption with daily regimens.

Ineffectiveness of daily iron supplementation programs in the developing countries have been attributed to

1. 
   Low compliance by subjects, particularly because of discomfort when taking daily iron tablets leading to non adherence to treatment.
   
2. 
   Low motivation and ability of health workers to provide appropriate counselling.
   
3. 
   Limited availabilityof supplies due to insufficient funds andproblems in the procurement and distribution of supplements.
   
4. 
   Inaccessibility, that is problems with cost, time and efforts required to reach a health centre where iron tablets are available.
   

A debate has developed in the past 5 years in the developed countries regarding the desirability of intermittent iron supplementation compared with daily regimen. The hypothesis behind the intermittent iron supplementation has been based on “mucosal block” theory of iron absorption. According to this theory, down regulation of iron absorption occurs by mucosal enterocytes when exposed to a daily high intake of iron.⁷

Studies conducted in other countries among children , pregnant and reproductive age women have demonstrated that weekly iron folic acid therapy/ supplementation can improve the iron status in of these groups when supplementation is continuous for periods from months to years.

In this context, the present study has been undertaken to find out the effectiveness of weekly versus daily iron supplementation to improve the iron status of the women. Weekly iron status is being looked into as it might lead to better compliance. In our Urban field practice area since quite a few women are anemic it will be worthwhile to find out if weekly supplement works better than daily supplement to improve the iron status of women in the reproductive age group.

6.2 Review of Literature

A randomized longitudinal study was conducted at Karachi, Pakistan comparing the effectiveness of daily versus weekly iron therapy for a period of 12 weeks among 110 pregnant women. The study subjects were divided randomly into 2 groups (n=55) and 200 mg ferrous sulphate was given for both weekly and daily groups.. At the end of the study period, haemoglobin values were 11.82 & 12.42g/dl for daily and weekly groups respectively. In that study they concluded that once weekly iron supplementation is good enough to maintain haemoglobin, serum ferritin, reticulocyte count, RBC count, MCV, MCH ,MCHC.⁷

A study conducted in Delhi comparing the effectiveness of weekly and daily iron therapy in reducing maternal anemia , for a period of 14 weeks. The pregnant women were randomized into 2 groups ( grp1-40, grp2-40) and given daily and weekly iron and folic acid(335mg ferrous sulphate & 500mg folic acid). At the end of 14 weeks there was similar increase in haemoglobin and hematocrit values in both the groups. In that study , they stated that weekly iron supplementation is equally effective in treating anemia.⁸

A Randomized control trial was done in Nagpur, Maharastra at Urban health training centre among adolescent girls for a period of 3 months. The anemic girls were randomly distributed into 2 groups and received daily and weekly supplements. Initial deworming and health education was given for both groups. The rise in haemoglobin in the respective groups was 1.0±7 & 1.0±8 g/dl. In that study they noted that weekly supplementation is as good as daily supplementation with added benefits of less adverse reactions and better compliance.⁹

A study conducted in Vietnam, reported the impact of 12 months implementation of WIFs/deworming intervention among women in the reproductive age group. Haemoglobin level was estimated using hemocue system, the prevalence of anemia at baseline was 37.5% and reduced to 28.4% & 19.3% at 3 months and 12 months post intervention. In that study they concluded that WIFS/ deworming was associated with reduced prevalence and severity of anemia in non-pregnant women over 12 month period.¹⁰

A randomized double blinded intervention trial was conducted in Bangladesh among female tea pluckers. A total of 280 women received either weekly iron supplementation (200mg ferrous fumarate & 200mg folic acid) for 24 weeks or a matching placebo.The mean haemoglobin in the supplemented group increased by 5.52 g/dl. Those individuals in the supplemented group with the lowest pre-trial haemoglobin and ferritin values experienced the greatest improvements post-trial. They concluded that weekly supplementation is simpler and cheaper than daily supplementation but would have to be continued on a long term basis in order to combat anemia and iron deficiency.¹¹

A study conducted in Jamaica comparing the haemoglobin values obtained by hemocue system with those from coulter counter S –Plus IV for a period of one year. The mean and standard deviation values for haemoglobin were 10.3 & 0.84 by hemocue & 10.1& 1.03 by coulter counter system . In that study they concluded that hemocue system of measuring haemoglobin was found to be convenient and easy to use by field workers and they recommended its use as a research tool in field studies where an accurate and rapid measurement of haemoglobin level is needed.¹²

6.3 Objectives

1. To describe the socio-demographic profile of the study subjects.

2. To find out the burden of anemia in the study subjects who are being screened for anemia.

3. To find out the effectiveness of weekly versus daily supplementation of oral iron and folic acid in the study subjects.

4. To assess the knowledge of the study subjects before and after health education session.

7. Subjects and methods

7.1 Place of study: Urban health centre, Department of Community Medicine, Kempegowda Institute of Medical Sciences,Bangalore.

7.2 Study period: one year and 6 months.

7.3 Study design:

• 
  Phase I : Cross sectional study
  
• 
  Phase II : Intervention study, comparing the effectiveness of daily versus weekly iron folic acid supplementation .
  

7.4 Sample size estimation:

Absolute precision

n=( Za/2)²pxq/d²

Za/2 = 1.96, p- Prevalence of anemia among reproductive age group according to NHFS III which is 56%.

q= 100-p

Taking precision 10%

= 1.96 x 1.96 x 0. 56 x 0.44

0.1 X 0.1

= 3.84 x 0. 56 x 0.44

0.1 X 0.1

= 94.65

~ 95.

7.5 Sampling method: Women in the reproductive age group will form the sampling frame. In our field practice area there are 893 women. These women will be screened during a house to house visit, screening shall be done till we get the required sample for our intervention study that is approximately 95 subjects.

7.6 Inclusion criteria

a. Women of reproductive age group who are willing to participate.

b. Mild Anemia and Moderate Anemia.

7.7 Exclusion criteria:

a. Pregnant and lactating women

b. Any known hemoglobinopathy.

c. Chronic disease of liver, CVS, kidney.

d. Currently taking or having taken therapeutic iron in the previous 6 months.

7.8 Methodology:

Phase -1: Cross sectional study

In Urban field practice area of Kempegowda Institute of Medical Sciences, Bangalore, an house to house survey will be conducted to identify the eligible study subjects. Assessment of women for signs of anemia will be done by clinical examination. Women who are found to be anemic clinically, their haemoglobin estimation will be done using Hemocue Hb 301 system. The eligible woman who are detected to be anemic and having haemoglobin value less than 12g/dl¹³(according to WHO) will be included in the study. Sociodemographic characteristics and other relevant medical history will be collected, using the predesigned and pretested standardized proforma and they will be randomly divided into two groups for the phase-2 study.

Phase-2: Intervention study

a) Informed written consent will be taken from all the subjects for the intervention study

b) Initial deworming will be done by giving 400mg albendazole single dose stat for both the groups.

GROUP 1: Baseline Haemoglobin reading will be done. Subjects would be visited on a weekly basis and provided with daily dose of iron and folic acid for the following week. Subsequently, such visits would be made every week in order to follow up and check empty blister packets and further daily doses would be renewed. At the end of 16 weeks haemoglobin level will be estimated.

GROUP 2: Baseline haemoglobin reading will be done. They will be given weekly oral iron and folic acid under supervision for 4months, and at the end of 16 weeks there haemoglobin estimation will be done.

A Pre and post test evaluation will be done in the study subjects to assess the knowledge regarding anemia, its causation, consumption of iron and folic acid tablets, its side effects and dietary supplements to improve the haemoglobin status.

7.9 Statistical analysis: Descriptive statistics and student t- test.

8. Ethical issues:

• 
  Blood sample will be taken by finger prick method to estimate the haemoglobin values.
  

• 
  Informed consent would be taken from the study subjects.
  
• 
  Advantage to the subjects: the report of haemoglobin values would be given free of cost.
  

9. References:

	1. Mishra P, Ahluwalia SK, Garg PK, Kar R, Panda GK. The prevalence of anaemia among reproductive age group (15-45 yrs) women in a PHC of rural field practice area of MM Medical College, Ambala, India. J Women’s Health Care 2012;1:113. 2. Deshmukh PK, Garg BS, Bharambe MS. Effectiveness of weekly supplementation of iron to control anaemia among adolescent girls of Nashik, Maharashtra, India.J Health PopulNutr 2008;26(1): 74–78. 3. Family Welfare Statistics in India. Statistics division, Ministry of Health and Family Welfare, New Delhi: Government of India; 2006;76. 4. Tolentino K, Friedman JF. An Update on Anaemia in Less Developed Countries. AmJ Trop Med Hyg 2007;77(1):44-51 5. Yip R, Ramakrishnan U. Experiences and Challenges in Developing Countries.J Nutr 2002;132(4):827-30. 6. DeMaeyer EM ,Dallman P, Michael Gurney J, Hallberg L, Sood SK, Srikantia SG. Preventing and controlling iron deficiency anaemia through primary health care. Geneva : World Health Organization; 1989. 7. Shamaila Khalid, ShanzaWaqar, Mahvish Faisal, S.I. Ahmad.Effectiveness of weekly Iron supplementation in anemia in pregnancy.Pakistan Journal of Pharmacology 2011; 28(1): 9-16. 8. Gomber S, Agarwal KN, Mahajan C, Agarwal N. Impact of daily versus weekly hematinic supplementation on anemia in pregnant women.Indian Pediatr 2002;39(4): 339–346. 9. Joshi M, Gumashta R.Weekly iron folate supplementation in adolescent girls—an effective nutritional measure for the management of iron deficiency anaemia.Glob J Health Sci 2013;5(3):188-94. 10.Casey GJ, et al.Weekly iron-folic acid supplementation with regular deworming is cost-effective in preventing anaemia in women of reproductive age in Vietnam.PLoS ONE 2011; 6(9): e23723.   11.Gilgen D, Mascie-Taylor CG. The effect of weekly iron supplementation on anaemia and on iron deficiency among female tea pluckers in Bangladesh.J Hum Nutr Diet 2001;14(3):185-90. 12. Hudson-Thomas M, Bingham KC,. Simmons WK. An evaluation of the HemoCue for measuring haemoglobin in field studies in Jamaica.Bull World Health Organ 1994; 72(3): 423–426. 13. WHO. Nutritional anaemias.Report of a WHO scientific group. World Health Organ Tech Rep Ser 1968;405:5-37.

9. Signature of the Candidate:

10. Remarks of the Guide: Anemia in our field practice area is very common and women in the reproductive age group do not comply to daily regimens of iron therapy. This study will be beneficial in highlighting the role of once a week iron therapy for correction of anemia and there by improving compliance to iron therapy.

11. Names and Designation:

11.1	Guide	DR.JAYANTHISRIKANTH,MD ASSOCIATE PROFESSOR Department of Community Medicine KIMS, Bangalore.
11.2	Signature
11.3	Head of the Department	DR. B. G. PARASURAMALU, MD PROFESSOR AND HEAD Department of Community Medicine KIMS, Bangalore.
11.4	Signature

12.1 Remarks of Chairman and Principal

12.2 Signature: