| CTRI Number |
CTRI/2020/11/028999 [Registered on: 09/11/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of multiple micronutrient supplement Vs iron and folic-acid supplement for anemia prophylaxis among pregnant women. |
|
Scientific Title of Study
|
A double blinded randomized controlled trial to compare the effectiveness of oral multiple micronutrient supplement Vs oral iron and folic-acid, for anemia prophylaxis among non-anemic pregnant women in rural Haryana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kapil Yadav |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Centre for Community Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dr_kapilyadav@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Yadav |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Centre for Community Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dr_kapilyadav@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjusha Ranjith |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Centre for Community Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
anjusha.ranjith01@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Anjusha Ranjith |
| Address |
Junior Resident,
Centre for Community Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 Anjusha Ranjith |
Govt. Hospital (CRHSP Ballabgarh) |
National Highway 2, Mathura road, Radhanagar, Ballabgarh, Faridabad, Haryana- 121004
Faridabad
HARYANA |
9567616570
anjusha.ranjith01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non-anemic pregnant women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iron and folic acid supplement |
1 tablet OD oral for 180 days |
| Intervention |
Multiple micronutrient supplement |
1 tablet OD oral for 180 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
(1) Pregnant women less than or equal to 12 weeks of gestation, (2) non-anemic with hemoglobin value between 11 g/dl and 14 g/dl, (3) those who are willing to stay at the current address during their entire pregnancy. |
|
| ExclusionCriteria |
| Details |
(1) If taking iron supplements for more than 1 month or received intravenous iron/ blood transfusion in the past 6 months, (2) diagnosed hypertension, overt diabetes, multiple pregnancy, (3) patient diagnosed with an illness which can alter the hemoglobin values including malabsorption, hemoglobinopathies, hemorrhage in the last 1 month etc., (4) diagnosed psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hemoglobin level |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in serum ferritin |
180 days |
| Change in serum Vitamin B-12 |
180 days |
| Change in serum folate |
180 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2020 |
| Date of Study Completion (India) |
09/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a double blinded, parallel group, non-inferiority randomized controlled trial comparing the safety and efficacy of oral multiple micronutrient supplement 1 tablet daily and oral iron and folic-acid supplement 1 tablet daily for 180 days in 200 non-anemic pregnant women, that will be conducted in 6 subcentres under PHC Chhainsa and 6 subcentres under PHC Dayalpur in Haryana, India. The primary outcome measure will be change in hemoglobin level after 180 days of supplementation. The secondary outcomes will be change in serum ferritin levels , serum Vitamin B-12 levels and serum folate levels after 180 days of supplementation. |