Efficacy and Safety Study of Fixed Dose Combination Tablet of Iron Polymaltose and Folic Acid (Tablet Irpo- FA®) in Pregnant Women with Iron Deficiency Anaemia.
Objective: To evaluate safety and effectiveness of Test Product; irpo-FA Tablets in Prergnant women with irondeficiency Anemia. Inclusion Criteria: Pregnant Women in second or third trimester or after 12 weeks of pregnancy, Hb: ≤ 10. 5g/dl after first trimester and serum ferritin levels are below than normal (less than 35 μg/l)
Exclusion Criteria: Patient with a history of non-compliance with iron therapy or allergic to iron preparation.
Study Population: Pregnant Women Sample Size: 50 subjects
Intervention: Irpo-Fa ® Iron(III)Hydroxide Polymaltose 100mg; Elemental Iron Folic Acid 0.5 mg,
Main Outcomes measures: Increase in Hb level at 2 weeks, 1 month, 2 months and three months after initiation of oral iron therapy, Correction in anaemia within or on completion of three months of treatment.
General information
Acronym
None
IRCT registration information
IRCT registration number:IRCT201610197978N3
Registration date:2016-10-31, 1395/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Tasneem Ahmad
Name of organization / entity
Pharma Professional Services, Karachi, Pakistan
Country
Pakistan
Phone
(92-21) 34972358, 34820573
Email address
tasneem.ahmed@iccs.edu
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Company
Expected recruitment start date
2015-04-15, 1394/01/26
Expected recruitment end date
2016-01-18, 1394/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Safety Study of Fixed Dose Combination Tablet of Iron Polymaltose and Folic Acid (Tablet Irpo- FA®) in Pregnant Women with Iron Deficiency Anaemia.
Public title
Efficacy and Safety Study Tablet ( Irpo- FA®) in Pregnant Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant Women in second or third trimester or after 12 weeks of pregnancy, Hb: ≤ 10. 5g/dl after first trimester and serum ferritin levels are below than normal (less than 35 μg/l)
Exclusion Criteria: Patient with a history of non-compliance with iron therapy or allergic to iron preparation.
Age
From 18 years old to 40 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Single arm, Open label study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jinnah Post Graduate Medical Centre
Street address
Rafiqui Shaheed Road, Jinnah Post Graduate Medical Centre
City
karachi
Postal code
75510
Approval date
2015-02-14, 1393/11/25
Ethics committee reference number
NO.F.2-81/2015-GENL/11128/JPMC
Health conditions studied
1
Description of health condition studied
Iron Deficiency & Folic acid Deficiency anemia
ICD-10 code
D-50 & D-5
ICD-10 code description
Iron deficiency anaemia, unspecified & Folate deficiency anaemia, unspecified
Primary outcomes
1
Description
Increase of 1g/dl Hb with 100-200mg/day elemental iron
Timepoint
2 weeks, 1 month, 2 months and three months after initiation of oral iron therapy
Method of measurement
C. B. C, Ferritin, iron profile tests
Secondary outcomes
1
Description
Gastrointestinal adverse events
Timepoint
At every visit and Follow up checkups
Method of measurement
Patient monitoring & Follow up calls to patients
Intervention groups
1
Description
Each patient received irpo-FA (combination tablet of Iron Polymaltose (100mg elemental iron) & 0.35 mg folic acid oral tablets O. D, following the instructions as chew the tablets on empty stomach, 1 hour before or after meal for 3 months as prescribed by the doctor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Jinnah Postgraduate Medical Centre (JPMC)
Full name of responsible person
Dr. Haleema Yasmeen
Street address
Department of Gynecology, Jinnah Postgraduate Medical Centre (JPMC)
City
Karachi
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nabiqasim Industries (Pvt) Ltd.
Full name of responsible person
Mohammad Younus Batla
Street address
510, 5th floor, commerce center, Hasrat Mohani Road
City
Karachi.
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nabiqasim Industries (Pvt) Ltd.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nabiqasim Industries (Pvt) Ltd.
Full name of responsible person
Salman Rahim
Position
Assistant Manager Regulatory Affairs.
Other areas of specialty/work
Street address
510, 5th floor, commerce center, Hasrat Mohani Road
City
karachi
Province
Sindh
Postal code
74200
Phone
009221 32636313
Fax
Email
salman.rahim@nabiqasim.com
Web page address
www.nabiqasim.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Gynaecology, Jinnah Post Graduate Medical Centre
Full name of responsible person
Dr. Haleema Yasmeen
Position
Assistant Professor
Other areas of specialty/work
Street address
Rafiqui Shaheed Road, Jinnah Post Graduate Medical Centre
City
karachi
Province
Sindh
Postal code
75510
Phone
92-21-99201300
Fax
Email
dr.haleemayasmin@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pharma Professional Services
Full name of responsible person
Prof.Dr. Tasneem Ahmad
Position
Chief Investigator
Other areas of specialty/work
Street address
A-93, Ettawah Society, scheme 33
City
Karachi
Province
Sindh
Postal code
75343
Phone
00922136352328
Fax
Email
dr.tasneem@phaps.com
Web page address
www.phaps.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)