| CTRI Number |
CTRI/2025/04/084204 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the benefits of starting oral iron supplements in the first trimester of pregnancy in reducing the occurrence of anemia during pregnancy |
|
Scientific Title of Study
|
A randomized controlled double-blind trial to evaluate the benefits of starting oral iron supplements in the first trimester, in reducing prevalence of anemia during pregnancy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Molly Jacob |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Biochemistry, Christian Medical College, Bagayam, Vellore, Tamil Nadu, India
Bagayam, Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
09894494337 |
| Fax |
0416 2262788 |
| Email |
mjacob@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Molly Jacob |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Biochemistry, Christian Medical College, Bagayam, Vellore, Tamil Nadu, India
Bagayam, Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
09894494337 |
| Fax |
0416 2262788 |
| Email |
mjacob@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Molly Jacob |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Biochemistry, Christian Medical College, Bagayam, Vellore, Tamil Nadu, India
Bagayam, Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
09894494337 |
| Fax |
0416 2262788 |
| Email |
mjacob@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi - 110029, India |
| 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 Molly Jacob |
Christian Medical College Vellore |
Department of Obstetrics and Gynecology,
Christian Medical College, Ida Scudder Road, Vellore- 632004
Vellore
TAMIL NADU |
09894494337
0416 2262788
mjacob@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No oral iron of folic acid supplementation in the first trimester |
Placebo (0 mg elemental iron + 0 mcg folic acid daily) started at the time of recruitment in the first trimester (at gestational ages between 4 and 8 weeks) till end of 12 weeks of gestation
|
| Intervention |
Oral iron and folate supplementation started in first trimester
|
Oral iron and folate supplementation (30 mg elemental iron + 500 mcg folic acid) daily, started at time of recruitment in the first trimester (at gestational ages between 4 and 8 weeks) till the end of 12 weeks of gestational age |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women who conceived naturally
With singleton uncomplicated pregnancies
Who plan to deliver their babies in CMC, Vellore
Willing to be randomised to an intervention and to be followed up
Those who continue till delivery, with no complications of pregnancy
|
|
| ExclusionCriteria |
| Details |
Those with multiple fetuses
Those with any documented complication of pregnancy
Those who develop any complication of pregnancy subsequently, after recruitment
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Comparison of the proportion of anemic and/or iron-deficient women among those who receive and do not receive oral iron supplements (OIS) in the first trimester
2. Comparison of hematological and iron-related indices in women who receive and do not receive OIS in the first trimester |
At the time of delivery of each woman in the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of hematological & iron-related indices in cord blood from women who receive & do not receive OIS in the first trimester
2.Compare iron-related parameters in placentae of a subgroup of women who receive & do not receive OIS in the first trimester |
At the time of delivery of each woman in the study |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Rationale/ gaps in existing knowledge Iron deficiency (ID) is highly prevalent in the first trimester of pregnancy. However, current guidelines of the Anemia Mukt Bharat program in India do not recommend oral iron supplements (OIS) in the first trimester. It is unclear whether such supplementation would be beneficial to reduce iron deficiency and anemia during pregnancy. This proposal aims to address this lacuna.
Novelty There is little Indian data on the benefits of starting OIS in the first trimester of pregnancy, instead of only in the second trimester (current national recommendations), to reduce iron deficiency and anemia during pregnancy. This is an important question to answer, given the burden of anemia in pregnancy in India.
Objectives To compare the effectiveness of starting OIS in the first trimester versus starting it only in the second trimester, in reducing the prevalence of anemia during pregnancy.
Methods and expected outcomes In a randomized controlled double-blind trial, pregnant women will receive either placebo or low-dose (30 mg elemental iron) OIS in the first trimester. From the second trimester onwards, they will all receive supplements as per standard of care. Participants will be monitored through pregnancy till delivery. Blood samples will be obtained in each trimester and at the time of delivery. Cord blood and placental tissue samples will also be obtained.
The proportion of women in each group with ID/anemia at delivery will be ascertained. Blood samples will be used for estimation of hematological and iron-related indices. Placental tissue will be used to determine indices related to iron homeostasis. Outcomes of pregnancy will be documented.
|