| CTRI Number |
CTRI/2017/07/009110 [Registered on: 26/07/2017] Trial Registered Prospectively |
| Last Modified On: |
26/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Iron Rich Food Supplement] |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of percentage and factors determining iron deficiency anaemia and to check the impact of iron rich food supplement on the improvement of haemoglobin level in blood and working effeciency of selected female cashew factory workers(18-25year), moodbidri, karnataka |
|
Scientific Title of Study
|
Assessment of prevalence and determinants of IDA and impact of iron rich food supplement on improvement of Hb. levels and working efficiency of selected female cashew factory workers (18-25 years), Moodbidri, Karnataka. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shefali Hemant Chakke |
| Designation |
Msc DAN 2nd year semester |
| Affiliation |
Dept. of Allied Hospitality Studies, WGSHA, Manipal |
| Address |
Department of Allied Hospitality Studies, WGSHA, Manipal.
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9833059982 |
| Fax |
|
| Email |
shefaliparulekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi Garg |
| Designation |
Asst.Prof._Selection Grade and HOD M.Sc. Dietetics and Applied Nutrition |
| Affiliation |
Dept. of Allied Hospitality Studies, WGSHA, Manipal |
| Address |
Department of Allied Hospitality Studies, WGSHA, Manipal.
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
934316327 |
| Fax |
|
| Email |
meenakshi.garg@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva Kamath |
| Designation |
Msc DAN 2nd year semester |
| Affiliation |
Dept. of Allied Hospitality Studies, WGSHA, Manipal |
| Address |
Department of Allied Hospitality Studies, WGSHA, Manipal.
Dakshina Kannada
KARNATAKA
5776104
India |
| Phone |
9986520414 |
| Fax |
|
| Email |
apoorvakamath11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ananth Kamath Agro Industries, Puttige Padavu, Sampige-post, Moodbidri, Mangalore, Dakshina Kannada, Karnataka Pin-574227 |
| Sri Shantha Durga Cashew Processors, Kallamundkur, Banangady-post, Mangalore, Dakshina Kannada, Karnataka Pin-574227 |
|
|
Primary Sponsor
|
| Name |
Meenakshi Garg |
| Address |
Asst. Prof._Selection Grade and HOD M.Sc Dietetics and Appplied Nutrition, Department of Allied Hospitality Studies, WGSHA, Manipal-576104 |
| Type of Sponsor |
Other [HOD of MSc DAN] |
|
|
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 |
| Shefali Hemant Chakke |
Sri Ananth Kamath Agro Industries and sri shantha durga cashew processors |
1.Mr. Vivekananda Kamath,
Sri Ananth Kamath Agro Industries, Puttige Padavu, Sampige-post, Moodbidri, Mangalore.pin-574227
2.Mrs.Akshatha kamath,
kallamundkur, banangady post, moodbidri. pin-574227
Dakshina Kannada
KARNATAKA |
9833059982
-
shefaliparulekar@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Iron Deficiency Anaemia with Hb level 10-12g/dl |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group having Hb.level 10-12g/dl and are given only counselling |
Control group will be given education material and Hb. levels will be monitored with a drop of blood (finger prick) on a strip, using Arkrey’s Hemoglobin meter three times during the study i.e. at the end of 4th, 8th and 12th week. Dietary recall, symptoms score and anthropometric measurements will be taken twice during the study, i.e. at the end of 6th and 12th week. |
| Intervention |
Intervention group having Hb.level 10-12g/dl and given iron rich food supplement. |
Iron rich food supplement will be provided on alternate days for 12 weeks. Hb. levels will be monitored with a drop of blood (finger prick) on a strip, using Arkrey’s Hemoglobin meter three times during the study i.e. at the end of 4th, 8th and 12th week. Dietary recall, symptoms score and anthropometric measurements will be taken twice during the study, i.e. at the end of 6th and 12th week. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Phase-1:- Selected female cashew factory workers of 18-25 years from two factories.
Phase-2:- Female cashew factory workers Hb. level from 10-12g/dl. |
|
| ExclusionCriteria |
| Details |
Phase-1:-
1. Women below 18 years old and above 25 years old.
2. Women with co morbid condition or immune compromised patients.
3. Female cashew factory other than the 2 factories mentioned above.
4. Pregnant and Lactating mothers.
5. Not willing to be part of the study
Phase-2:-
1. Women having Hb. levels less than 10g/dl or
more than or equal to 12g/dl.
2. Women with co-morbid condition or immune- compromised patients.
3. Any proven food allergies to the ingredients in the supplement given.
4. Having Hb levels between 10-12 g/dl but not willing to be part of study. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparing the difference in Hb. levels & work efficiency among intervention group and control group, after supplementation with a homemade iron rich food supplement.
|
baseline of 0, 4th, 8th and 12th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identifying the prevalence and determinants of iron deficiency anemia. |
1 hour with each participant for the collection of data |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
31/07/2017 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Iron deficiency anemia is a most common micronutrient disorder which affects negatively the health and the socioeconomic wellbeing of an individual. It is mainly associated with the poverty, limited access to appropriate healthcare and treatment and also lack of education regarding iron rich foods.Through this study we are going to determine the prevalence and determinants of IDA and to compare the improvement in Hb levels and work efficiency in control and experimental by giving them simple homemade iron rich food supplements using common ingredients. |