Skip to main content
Clinical Trials/CTRI/2025/12/098428
CTRI/2025/12/098428Not yet recruitingNot Applicable

Effect of maternal zinc supplementation on pregnancy complications and outcomes - A Randomized Controlled Trial in a Tertiary Care Hospital

MRU1 site in 1 country150 target enrollmentStarted: December 16, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
MRU
Enrollment
150
Locations
1
Primary Endpoint
Low Birth weight

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Double

Eligibility Criteria

Ages
15.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • History of renal disease, hypertension and diabetes.

Outcomes

Primary Outcomes

Low Birth weight

Time Frame: Low Birth weight at the time of delivery

Secondary Outcomes

  • PIH(premature rupture of membrane)

Investigators

Sponsor
MRU
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

DrGSridevi

Rangaraya medical college

Study Sites (1)

Loading locations...

Similar Trials