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
|
|
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
|
|
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. |