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CTRI Number  CTRI/2024/03/063712 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Nutritional Status in the females in the Rural Areas of Aligarh  
Scientific Title of Study   Study of Nutritional Status among the Females of Reproductive Age Group in the Rural Area of Aligarh District of Uttar Pradesh 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lovely Singh 
Designation  PG Scholar 
Affiliation  Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 
Address  Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India 
Phone  6396359982  
Fax    
Email  lovely120920@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof S M Safdar Ashraf 
Designation  Chairman Department of Tahaffuzi wa Samaji Tib  
Affiliation  Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 
Address  Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India 
Phone  7300530183  
Fax    
Email  syedmsashraf@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  ProfS M Safdar Ashraf 
Designation  Chairman Department of Tahaffuzi wa Samaji Tib  
Affiliation  Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 
Address  Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India 
Phone  7300530183  
Fax    
Email  syedmsashraf@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College Faculty Of Unani Medicine AMU Aligarh 
 
Primary Sponsor  
Name  Department of Tahaffuzi wa Samaji Tib  
Address  Department of Tahaffuzi wa Samaji Tib Ajmal Khan Tibbiya College AMU Aligarh 202002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Lovely Singh  Ajmal Khan Tibbiya College and Hospital  Ajmal Khan Tibbiya College and hospital, AMU in front of BSNL telephone exchange office, Aligarh, 202002
Aligarh
UTTAR PRADESH 
6396359982

lovely120920@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nutritional Status 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Observational study  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  1. Age group- 15 to 49 years.
2. Healthy females
3. Without any disorder
4. Married and unmarried both
5. Rural area
6. Patients who have agreed to sign informed consent and follow up the protocol.
 
 
ExclusionCriteria 
Details  1. Patients below the age of 15 and above the age of 49 years
2. Females having pregnancy and lactations
3. Patients having co-morbidity like CVD with renal diseases.

• Males and children.
• Urban areas.
• Patients who are not ready to sign informed consent and follow up the protocol.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of malnourished women
Number of overweight women
Number of obese women 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Healthy women of reproductive age group  Assessment of general awareness and practices of rural women regarding nutrition, health and sanitary practices 
 
Target Sample Size   Total Sample Size="284"
Sample Size from India="284" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The diets of women in India often too poor to meet their nutritional needs. A quarter of women of reproductive age in India are undernourished, with a body mass index of less than18.5kg/m2. It is well known that an undernourished mother inevitably gives birth to an undernourished baby, perpetuating an intergenerational cycle of under nutrition. 

Five essential nutrition interventions for mothers include: 

1.      Improving the quantity and nutrient level of food consumed in the household.

2.      Preventing micronutrient deficiencies and anemia.

3.      Increasing women’s access to basic nutrition and health services.

4.      Improving access to water and sanitation, health education and other facilities, by providing sanitation and hygiene education, including menstrual hygiene.

5.      Empowering women to prevent pregnancies too often and too close together.

 

According to NFHS III data, more than a third (36%) of women has a BMI below 18.5, indicating a high prevalence of nutritional deficiency. Among women who are thin, 44% are moderately or severely thin. More than half of the women (55%) are anemic as depicted by NFHS III survey. Less than one-third of women in the lowest wealth quintile consume milk or curd at least once a week, as do less than half of women in the second wealth quintile. More than half of women in the three highest wealth quintiles consume milk or curd at least once a week. In the highest wealth quintile, three-quarters of women consume milk or curd at least once a week. The differentials in food consumption are even sharper for the consumption of fruit. Weekly consumption of fruit increases from 16 percent in the lowest wealth quintile to 72 percent in the highest wealth quintile. 

In this regard, a study is being designed to evaluate the nutrient intake among the rural females of Aligarh district in their reproductive years along with associated health consequences and the factors which are responsible for the nutritional status.

 
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