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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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