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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03353662 -
Sub Regional Micronutrient Survey in Ethiopia
|
||
Completed |
NCT02126293 -
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
|
Phase 3 | |
Terminated |
NCT01472211 -
Water-based Zinc Intervention Trial in Zinc Deficient Children
|
Phase 0 | |
Completed |
NCT01061307 -
An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
|
Phase 0 | |
Recruiting |
NCT03421314 -
Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.
|
N/A | |
Completed |
NCT02292303 -
Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
|
N/A | |
Completed |
NCT02241330 -
Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status
|
N/A | |
Completed |
NCT01221129 -
Zinc and the Synthesis of Zinc Binding Proteins (Protocol B)
|
N/A | |
Completed |
NCT04632771 -
Nutritional Status and Bouillon Use in Northern Ghana
|
||
Recruiting |
NCT05236374 -
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
|
N/A | |
Completed |
NCT02760095 -
Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
|
||
Completed |
NCT02758444 -
Effects of EED on Zn Absorption and Retention in Children From a MNP
|
N/A | |
Completed |
NCT02233764 -
Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India
|
N/A | |
Recruiting |
NCT05527899 -
Zinc Intervention in Elderly for Prevention of Pneumonia
|
Phase 2/Phase 3 | |
Terminated |
NCT04983667 -
Zinc-AA Supplementation During Pregnancy & Lactation to Assess Effects on ASD Prevalence in Offspring
|
N/A | |
Completed |
NCT03293641 -
Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya
|
N/A | |
Completed |
NCT05778383 -
Zinc Supplementation Impact in Acute COVID-19 Clinical Outcomes
|
Phase 4 | |
Completed |
NCT01062347 -
A Novel Bio-marker of Zinc Status
|
Phase 1 | |
Recruiting |
NCT05085834 -
Zinc Effect on Inflammation and Cardiovascular Risk in HIV
|
Early Phase 1 | |
Completed |
NCT02321865 -
Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency
|
Phase 3 |