| CTRI Number |
CTRI/2025/12/098428 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Other (Specify) [ZINC SUPPLEMENTATION] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the effectiveness of of Zinc supplementation among pregnant mothers to improve birth weight of babies |
|
Scientific Title of Study
|
Effect of maternal zinc supplementation on pregnancy complications and outcomes - A Randomized Controlled Trial in a Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGSridevi |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Rangaraya medical college |
| Address |
Dept of community medicine
Rangaraya medical college
Kakinada
East Godavari ANDHRA PRADESH 533004 India |
| Phone |
09441609563 |
| Fax |
|
| Email |
shridevigarapati@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrGSridevi |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Rangaraya medical college |
| Address |
Dept of community medicine
Rangaraya medical college
Kakinada
East Godavari ANDHRA PRADESH 533004 India |
| Phone |
09441609563 |
| Fax |
|
| Email |
shridevigarapati@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DrGSridevi |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Rangaraya medical college |
| Address |
Dept of community medicine
Rangaraya medical college
Kakinada
East Godavari ANDHRA PRADESH 533004 India |
| Phone |
09441609563 |
| Fax |
|
| Email |
shridevigarapati@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MRU, Rangaraya Medical College, kakinada, Andhra pradesh, India -533001 |
|
|
Primary Sponsor
|
| Name |
MRU |
| Address |
Rangaraya Medical College,Kakinada, Andhra Pradesh, India -533001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrGsridevi |
Rangaraya Medical College |
Department of Community Medicine, Government General Hospital
KAKINADA
ANDHRA PRADESH 533001 East Godavari ANDHRA PRADESH |
09441609563
shridevigarapati@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RANGARAYA MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O429||Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMPARATOR ARM - PLACEBO OR NIL |
PLACEBO IN ANY FORM OF SUPPLEMENTATION IS NOT GIVEN |
| Intervention |
INTERVENTION GROUP - ZINC SUPPLEMENTATION |
zinc tablets 30mg ONE tablet per day given orally . Given from time of enrolment into study to till the time of delivery. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women coming to Antenatal OPD on alternate day carrying a singleton foetus and 12–16 weeks of gestation with no history of renal disease hypertension diabetes. willing to have their delivery in Government General hospital Kakinada and willing to provide informed written consent will be included in the study. |
|
| ExclusionCriteria |
| Details |
History of renal disease, hypertension and diabetes
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Low Birth weight |
Low Birth weight at the time of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PIH
premature rupture of membrane |
During the Pregnancy period |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
16/12/2025 |
| 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="1" 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
|
· All the eligible pregnant women were screened for Zn levels, those below normal Reference range. · Investigator will provide monthly supply of zinc to the pregnant women and instructed the women to consume one tablet daily between meals and not together with other vitamin or mineral supplements. Compliance with this regimen was assessed by counting the remaining tablets in each strip at the next visit. · Its A Randomized controlled Clinical Trial (double blinded) in Government general Hospital, Kakinada for a period of One year among Pregnant women who are attending OBG OPD, GGH, Kakinada. · Pregnant women carrying a singleton foetus, at 12–16 wks of gestation , willing to have their delivery in Kakinada and provided informed written consent will be included. Having History of renal disease, hypertension and diabetes were excluded · Pregnant women would be consecutively assigned into study and control group. Zn estimation was done at the time of enrollment, at 28wks of gestation and at the time of delivery (3times). For The intervention arm Zinc supplementation would be given at the time of enrollment into the study and continued till delivery (maximum of 28wks)-30mg elemental Znso4/day . · Maternal outcome Measures: PIH, Pre-eclampsia, premature rupture of membrane, APH, PPH, caesarean, instrumental delivery · Neonatal Outcome Measures : Stillbirth, neonatal death, preterm birth , small for gestational age (SGA), low birth weight (LBW), length and head circumference, 5-minute APGAR score , MUAC. |