| CTRI Number |
CTRI/2024/09/073361 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial to study the effect of iron supplement ferrous ascorbate on regular blood donors. |
|
Scientific Title of Study
|
Effectiveness of ferrous ascorbate as a
supplementation therapy in regular
voluntaryblood donors. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Narwal |
| Designation |
PhD Scholar |
| Affiliation |
Chitkara University,Punjab |
| Address |
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09466852235 |
| Fax |
|
| Email |
neha.narwal207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Narwal |
| Designation |
PhD scholar |
| Affiliation |
Chitkara University,Punjab |
| Address |
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09466852235 |
| Fax |
|
| Email |
neha.narwal207@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Narwal |
| Designation |
Phd Scholar |
| Affiliation |
Chitkara University,Punjab |
| Address |
rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09466852235 |
| Fax |
|
| Email |
neha.narwal207@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neha Narwal
Chitkara University |
|
|
Primary Sponsor
|
| Name |
Neha Narwal |
| Address |
KCGMC ,Karnal 132001 India |
| 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 |
| Dr Anup Singh |
Aashirwad blood centre |
RJ super speciality hospital,Bahadurgarh
Jhajjar
HARYANA |
9818493920
anupboora65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chitkara University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Blood donors. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age of donor 18-65 years, Hemoglobin 12.5-16.5 g %, weight more than 45 kg, voluntary blood donor who has donated at least three times, the last donation being within the previous year, and continues to donate regularly at least once per year and other criteria as per NACO guidelines |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Donors ferritin levels are low but their hemoglobin levels are normal,they may not be aware of this condition. |
45 DAYS-60DAYS-90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Donors ferritin levels will improve after taking the medicine. |
90 DAYS |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/09/2024 |
| 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="0"
Months="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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 primary objective of my study was to investigate the effectiveness of ferrous ascorbate supplementation among regular blood donors. A total of 160 donors were enrolled in the study through organized camps. Among them, 80 donors were assigned to receive ferrous ascorbate, while the remaining 80 donors formed the control group and did not receive any medication.
The study was structured with weekly follow-up sessions to closely monitor the donors who were administered ferrous ascorbate. This systematic approach allowed us to track any changes or improvements in their health status and blood donation outcomes over time.
Throughout the study period, meticulous records were kept of each donor’s health parameters, including hemoglobin levels, iron status, and general well-being. Positive trends and improvements were noted particularly among those who received ferrous ascorbate, suggesting a potential benefit of the supplementation in maintaining or enhancing their ability to donate blood regularly. In conclusion, the findings of this study highlight promising outcomes associated with ferrous ascorbate supplementation among regular blood donors. |