| CTRI Number |
CTRI/2022/11/047376 [Registered on: 17/11/2022] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial of Iron supplement in anemic pregnant women. |
|
Scientific Title of Study
|
Clinical investigation of efficacy and safety of iron supplement in pregnant women affected by iron deficiency anemia. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MHC/CT/22-23/006 Version: 2.00 dated 25 March 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Adhav Tejasvini Kishor |
| Designation |
Consultant Gynecologist |
| Affiliation |
Lifepoint Multispeciality Hospital |
| Address |
3rd Floor, Clinical Research Department,145/1, wakad
Pune
MAHARASHTRA
411057
India |
| Phone |
8805785212 |
| Fax |
- |
| Email |
adhav.tejasvini121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Shah |
| Designation |
Technical Consultant |
| Affiliation |
Generex Pharmassist Pvt. Ltd. |
| Address |
136/B Shanti Nagar Building 13th Floor, B Building 98 Nepean Sea
Road
Mumbai
MAHARASHTRA
400006
India |
| Phone |
9867385041 |
| Fax |
- |
| Email |
shahalok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Srivastav |
| Designation |
Manager - Science and Technical Marketing |
| Affiliation |
Generex Pharmassist Pvt. Ltd. |
| Address |
T.V Industrial Estate, 21 - 23, Hind Cycle Marg, Worli
Mumbai
MAHARASHTRA
400030
India |
| Phone |
9136554279 |
| Fax |
- |
| Email |
technical@generex.in |
|
|
Source of Monetary or Material Support
|
| Generex Pharmassist Pvt. Ltd. T.V Industrial Estate, 21 - 23, Hind Cycle Marg, Worli, Mumbai, Maharashtra 400030 |
|
|
Primary Sponsor
|
| Name |
Generex Pharmassist Pvt. Ltd. |
| Address |
T.V Industrial Estate, 21 - 23, Hind Cycle Marg, Worli, Mumbai,
Maharashtra 400030 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adhav Tejasvini Kishor |
Lifepoint Multispeciality Hospital |
3rd Floor, Clinical Research
Department,145/1, wakad
Pune
MAHARASHTRA |
8805785212
-
adhav.tejasvini121@gmail.com |
| Dr Shilpa P Kshirsagar |
Lokmanya Medical Research Centre and Hospital |
Forth floor OPD 401, 314 B Telco Road, Chinchwad
Pune
MAHARASHTRA |
9689904101
-
Shilpakshirsagar.g@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Iron supplement 30 mg |
30 mg Iron supplement(Emulsified Ferric Pyrophosphate) tablet
once a day for 16 weeks. |
| Intervention |
Iron supplement 60 mg |
60 mg Iron supplement(Emulsified Ferric Pyrophosphate) tablet
once a day for 16 weeks (2
tablets of 30 mg) |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant females with age between 18-40 years (Both inclusive) 2. Presence of a live, singleton, intrauterine fetus and dating ultrasound at screening that indicates a pregnancy that would be between week 13 to week 20 (both inclusive) 3. Female with primi or multigravida 4. Pregnant females without any other comorbidity 5. Hemoglobin levels between 9-10.5 gm/dl (Bothinclusive) 6. With or without the fatigue associated with anemia 7. Serum ferritin levels between 10-15 mcg/L (Both inclusive) 8. Able to give written informed consent 9. Able to follow up through visits. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women of less than 13 weeks and more than 20 of gestation;2.Pregnant female with complicated pregnancy history or ongoing treatment for the same;3.Pregnant women with complications like bleeding piles, excessive emesis, active peptic ulcer, diabetes, hypertension, eclampsia, hypothyroidism and hyperthyroidism and multiple pregnancy;4.Fetal anomaly if detectable when an initial ultrasound is done to date the pregnancy;
5.Subjects on any concomitant therapy for treating IDA during study period 6.Not willing to provide consent or follow up; 7.Any condition from investigator viewpoint can affect patient participation in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1.Changes in hemoglobin levels between groups on screening and every follow up visit till end of the study |
Screening, week 4, week 8,and week 12 and week 16 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Changes in Ferritin levels between groups on screening & every follow up visit till end of the study.
2.Changes in fatigue severity score between groups on screening & every follow up visit till end of the study.
3.Changes in serum iron between groups at screening & end of the study.
4.Changes in score of symptoms related to iron deficiency as well as gastrointestinal events between groups after iron supplementation such
as breathlessness, palpitations, headaches,
dizziness, irritability & constipation, abdominal
discomfort, nausea & heartburn on 4-point ordinal scale. (0- none, 1- mild, 2- moderate, 3- severe) on screening, baseline, & every follow up visit till end of the study |
Screening, week 4, week 8,and week 12 & week 16 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
21/11/2022 |
| 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
Modification(s)
|
Years="0"
Months="7"
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)?
Response - NO
|
|
Brief Summary
|
The present research is an attempt to clinically validate the effectiveness of Iron supplement with different doses in pregnant patients suffering from iron deficiency anemia (IDA). With the present research, we can apply the knowledge from previous studies and clinical trials to address important medical needs in pregnant IDA to improve effectiveness and reduce the anticipated side effects with better compliance in improving IDA status. We can utilize these outcomes to develop a strategy for treating IDA in pregnant females in a more appropriate and assured way. |