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

Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559152
• Other study ID #: 9/UN5.2.3.1/PPM/KP-DRPM/2019
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: September 2020
• Source: Universitas Sumatera Utara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients and Study Design This was an experimental study with pre-test/post-test control groups, double-blind with randomization block technique. This study was conducted from March to December 2019 in the obstetrics and neonatology unit of Universitas Sumatera Utara Hospital, Malahayati Islamic Hospital and Royal Maternity Hospital in Medan. Research subjects were pregnant mothers with their newborns who met the inclusion criteria. The study samples were divided into two groups and administered either zinc supplementation 20 mg/day or placebos, respectively, for 12 weeks. The zinc tablets or placebos were given in the morning after meals. All subjects were also given iron and folic acid tablets in accordance with the Indonesian government program. Subjects were healthy pregnant mothers in their second or third trimester, 20-35 years old, with a height of >150 cm and no indication of cons following this study, as determined by obstetrician and gynaecology specialists; subjects were enrolled with a consecutive sampling technique. Births involving twins, congenital abnormalities, prematurity (gestation age <37 weeks) or stillbirth were excluded.

Informed consent was given by all subjects' legal guardians following the provision of sufficient information prior to the study.

This study was approved by the Health Research Ethical Committee, School of Medicine, Universitas Sumatera Utara in accordance with the principles of the Helsinki Declaration (No.179/TGL/FK USU-RSUP HAM/2019).

Methods The parameters assessed in this study were maternal serum zinc levels, cord blood osteocalcin and birth length measurements. Maternal serum zinc levels were measured twice with 6 ml of vein blood each time, both during initial antenatal care and after 12 weeks of supplementation. Samples were subsequently centrifuged for 15 minutes at 3000 rpm. Specimens were processed by the inductively coupled plasma-mass spectrometry (ICP-MS) method using Agilent 7700 analyser (Santa Clara, USA, 2014). Normal serum zinc levels were defined based on a cut-off value of ≥ 56 µg/dL in accordance with Second National Health and Nutrition Examination Survey data from 1976-1980 (NHANES II).

Cord blood osteocalcin levels were measured with 6 ml cord blood samples prior to delivery, which were subsequently centrifuged for 15 minutes at 1000 rpm using Cobas e601 analyser (Roche Diagnostic, Mannheim, Germany) and N-Mid Osteocalcin (Abbexa) reagent. Osteocalcin was measured using the enzyme-linked immuno-sorbent assay (ELISA) method, and in accordance with Prodia clinical laboratory standards.

Neonatal birth length was performed with a SECA 232 digital baby scale for length with an accuracy of 0.1 cm. Maternal zinc intake was calculated in accordance with the NutriSurvey 2007 Indonesian version.

Statistical Analysis Descriptive analyses, correlation tests, and linear regression tests were performed using SPSS version 23.0 (SPSS Inc., Chicago, Illinois, USA). Statistical significance was considered at a p-value < 0.05 with a 95% confidence interval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy pregnant mothers in their second or third trimester

• Age 20-35 years old

• Minimal height 150 cm

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Birth Length
• Zinc Deficiency

Intervention

Dietary Supplement:
• Zinc Supplementation Group
Enrolled subjects received zinc capsule 20mg daily in the morning after meal for 12 weeks
• Placebo Group
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

Locations

Country	Name	City	State
Indonesia	Universitas Sumatera Utara	Medan	Sumatera Utara

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation Between Maternal Zinc Supplementation with Maternal Serum Zinc Levels	Maternal Serum Zinc level was measured before and after intervention. Participants dietary intake also will be accounted and calculated via food recall.; The serum zinc level before and after intervention will then be analysed statistically to check for any correlation between zinc dietary intake and serum zinc level	12 weeks