| CTRI Number |
CTRI/2014/10/005135 [Registered on: 22/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
20/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of daily and weekly iron effect during pregnancy |
|
Scientific Title of Study
|
Estimation of oxidative stress in pregnant women on daily versus weekly iron supplementation (An ICMR Task Force Study) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 5/7/165/06-RHN |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeta Kumar |
| Designation |
Scientist C |
| Affiliation |
ICMR |
| Address |
Div. Of RCH, Room 214, first floor, ICMR, New Delhi
E-62 Ansari nagar, east campus, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9313195247 |
| Fax |
01126588755 |
| Email |
neeta@icmr.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Kumar |
| Designation |
Scientist C |
| Affiliation |
ICMR |
| Address |
Div. Of RCH, Room 214, first floor, ICMR, New Delhi
E-62 Ansari nagar, east campus, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9313195247 |
| Fax |
01126588755 |
| Email |
neeta@icmr.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Kumar |
| Designation |
Scientist C |
| Affiliation |
ICMR |
| Address |
Div. Of RCH, Room 214, first floor, ICMR, New Delhi
E-62 Ansari nagar, east campus, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9313195247 |
| Fax |
01126588755 |
| Email |
neeta@icmr.org.in |
|
|
Source of Monetary or Material Support
|
| Indian council of Medical Research, New delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ansari nagar, new Delhi-29 |
| Type of Sponsor |
Government funding agency |
|
|
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 Suneeta Mittal |
HRRC AIIMS |
HRRC AIIMS, Department of Obs and gyne, AIIMS, New Delhi-110029
New Delhi
DELHI |
9313195247
01126588755
suneeta_mittal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Instituional ethical review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnancy and oral iron in daily versus weekly dose |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
100 mg iron folic acid tabs daily |
Daily dose of 100 mg iron folic acid tablet starting from 13-16 weeks of pregnancy till 6 weeks post partum as per recommendation of National anemia control program |
| Intervention |
200 mg iron and folic acid tablet once weekly |
200 mg iron and folic acid tablet weekly dose till 6 weeks postpartum. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Age 20-30 years
Hemoglobin is above 11 gm/dl
Middle socio-economic income group
|
|
| ExclusionCriteria |
| Details |
History of chronic ailment
Taking any iron preparation already at the time of enrollment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oxidative stress status in plasma of pregnant women taking oral iron in daily versus weekly doses for anemia prevention |
At three point of time tests were conducted. Oxidative stress, micro nutrient and diet were assessed at the time of enrollment 14-16 weeks of primi pregnancy, after 3 months of supplementation and third time at 6 weeks post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of pregnancy on oxidative stress, relationship of oxidative stress with birth outcome and effect of daily versus weekly iron on side effects, acceptability and mode of delivery |
At 3 point of time, blood samples and information were sought from study participants, at baseline (14-16 weeks pregnancy, thirst trimester, 6 weeks post delivery |
|
|
Target Sample Size
|
Total Sample Size="650"
Sample Size from India="650"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This randomized controlled clinical trial at a tertiary level hospital, recruited primi para women in 2 phases in their first trimester and supplemented oral iron in two schedules. One is 100 mg elemental iron daily and another is 200 mg elemental iron weekly. Detailed dietary history, oxidative stress parameters and micro-nutrients were tested to estimate the oxidative stress in normal pregnant women while supplementing iron in daily and weekly doses. After completion of 650 enrollments, data is under analysis for effect on total and subgroups, both ways. |