| CTRI Number |
CTRI/2024/09/073229 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Nutritional and Health Status in Rural Women of Sundargarh District through Dietary Interventions. |
|
Scientific Title of Study
|
Interventional Study on Multiple Micronutrient Deficiencies among Rural Women (15-49 years) of Sundargarh District, Odisha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Mishra |
| Designation |
Research Scholar |
| Affiliation |
Department of Home Science, MMV, BHU |
| Address |
Department of Home Science
Mahila Mahavidyalaya
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8249065003 |
| Fax |
|
| Email |
amishra@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Shankar |
| Designation |
Head and Professor |
| Affiliation |
Department of Community Medicine,IMS, BHU |
| Address |
Department of Community Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9454352721 |
| Fax |
|
| Email |
drrshankar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukta Singh |
| Designation |
Head and Professor |
| Affiliation |
Department of Home Science, MMV, BHU |
| Address |
Department of Home Science
Mahila Mahavidyalaya
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7376623033 |
| Fax |
|
| Email |
msingh@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aishwarya Mishra |
| Address |
Department of Home Science
Mahila Mahavidyalaya
Banaras Hindu University
Varanasi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Aditi Patnaik |
Subdega Community Health Centre |
Sundargarh
Sundargarh
ORISSA |
8763281876
pattnayakaditi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| State Research & Ethics Committee, Govt. of Odisha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E60||Dietary zinc deficiency, (2) ICD-10 Condition: E611||Iron deficiency, (3) ICD-10 Condition: E531||Pyridoxine deficiency, (4) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pre and Post Intervention |
The study aims to assess screening of micronutrient status among women. Intervention comprises of three steps: firstly, the product formulation and analysis of its composition. Subsequently, an organoleptic test will be employed to evaluate the sensory aspects of the developed product. Lastly, to check the impact by taking their blood parameters.
Duration of the follow up will be 8 months (two follow up will be taken, once in every four month) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Women giving consent to participate
Women showing any clinical signs and symptoms |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Women having any severe complications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The dietary intervention will include the nutritional remedies for specific micronutrient deficiency |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sustainable approach. It will educate and improve their nutritional and health status. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/09/2024 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study employs a diagnostic approach, comparing procedure accuracy through purposive sampling in Sundargarh district, Odisha. Specifically, Block Subdega Community Health Centre (CHC) was selected due to their concentrated rural population. The focus is on assessing the micronutrient and health status of the rural women population, utilizing a diagnostic framework. Various tools are employed to gather information aligning with the study’s objectives. A self-prepared questionnaire and personal interviews serve as the primary data collection methods, organized into distinct sections. Section one focuses on demographic profiling through personal interviews. Section two delves into socioeconomic aspects, dietary background, and nutritional knowledge through surveys. Section three involves assessing the nutritional and health status of tribal women using anthropometric measurements (height, weight, BMI), clinical signs, and a biochemical profile encompassing parameters such as serum iron, TIBC, transferrin saturation, plasma zinc, serum Vitamin D (25-Hydroxy), Vitamin B12. Section four involves the nutritional interventions encompassing two main strategies: 1) Formulation and Supplementation of Products, 2) Nutrition Education. Section five focuses on evaluating the effectiveness of these interventions for approximately 8 months (two follow-ups). Section six involves the analysis of gathered information. Statistical analysis will be done via SPSS and MS Excel, while the necessary hypothesis tests will be conducted to derive conclusions from the collected data. |