Zinc Supplementation During Pregnancy: Analysis of Maternal Serum Zinc, Cord Blood Osteocalcin and Neonatal Birth Length

NCT04559152 | Completed DMC

• 1 other identifier: 9/UN5.2.3.1/PPM/KP-DRPM/2019
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental study was conducted with pre-test/post-test control groups and double-blind randomization from March to December 2019 at Universitas Sumatera Utara Hospital and others in Medan. Subjects were pregnant mothers in second or third trimester and with their newborns who met the inclusion criteria. Subjects were divided into two groups and administered either zinc supplementation 20 mg/day or placebo, respectively, for 12 weeks. The parameters assessed were maternal serum zinc levels cord blood osteocalcin and birth length measurements.

Conditions

Zinc Deficiency; Birth Length

Keywords

Zinc; Maternal zinc; Osteocalcin; Birth length

Outcome Measures

Primary Outcomes (1)

• Zinc Supplementation During Pregnancy Prevent Stunting Occurence to the Newborn: Analysis of Maternal Serum Zinc, Cord Blood Osteocalcin and Neonatal Birth Length

  Maternal serum zinc level (after intervention) was measured and analysed statistically for its correlation with mean cord blood osteocalcin levels and median neonatal birth lengths

  12 weeks up to childbirth

Secondary Outcomes (1)

• Correlation Between Maternal Zinc Supplementation with Maternal Serum Zinc Levels

  12 weeks

Study Arms (2)

Zinc Supplementation Group

EXPERIMENTAL

Zinc capsule (20mg) was taken in the morning after meals once daily for 12 weeks. All subjects in this arm were also given iron and folic acid tablets in accordance with the Indonesian government program.

Dietary Supplement: Zinc Supplementation Group

Placebo Group

PLACEBO COMPARATOR

Placebo (sugar tablet) was taken in the morning after meals once daily for 12 weeks. All subjects were also given iron and folic acid tablets in accordance with the Indonesian government program. Each placebo tablet was inserted into a capsule of the same shape and color with zinc capsule

Dietary Supplement: Placebo Group

Interventions

Zinc Supplementation Group DIETARY_SUPPLEMENT

Enrolled subjects received zinc capsule 20mg daily in the morning after meal for 12 weeks

Zinc Supplementation Group

Placebo Group DIETARY_SUPPLEMENT

Enrolled subjects received placebo tablet, which was inserted into capsule of the same shape and color as zinc capsule, daily in the morning after meal for 12 weeks

Placebo Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Pregnant mothers and their newborn babies
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant mothers in their second or third trimester
• Age 20-35 years old
• Minimal height 150 cm

You may not qualify if:

• Pregnant mothers in high-risk conditions such as
• severe malnutrition
• eclampsia
• gestational diabetes
• liver diseases
• kidney diseases
• Neonatal with
• twin babies
• congenital anomalies
• prematurity (gestation age \<37 weeks)
• stillbirth

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Universitas Sumatera Utara

Medan, North Sumatra, 20155, Indonesia

Location

Related Publications (1)

• Rohmawati L, Keumala DS, Sitepu M. Maternal Zinc Intake and Its Correlation with Maternal Serum Zinc Levels and Neonatal Birth Weight/Length. Pak. J. Nutr., 19 (5): 245-252, 2020. DOI: 10.3923/pjn.2020.245.252

  RESULT

Study Officials

• Lili Rohmawati, Researcher

  Universitas Sumatera Utara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subjects were divided into two groups (zinc supplementation and a placebo (control) group). Researchers and the subjects did not know the type of zinc supplementation or placebo given. The blinding process is carried out by the research assistant to the subject in the field at the time of retrieval of the research data. The selection of samples for each group uses the blocked randomization technique.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zinc Supplementation During Pregnancy for the Prevention of Stunting: Analysis of Maternal Serum Zinc, Cord Blood Osteocalcin and Neonatal Birth Length

Model Details: An experimental study with pre-test/post-test control groups, double-blind with randomization block technique

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 22, 2020
• Study Start: March 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 30, 2019
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Agustus 2020
• Access Criteria: lily\ rahmawati234@yahoo.com

Locations

ID (1)