- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04559152
Zinc Supplementation During Pregnancy: Analysis of Maternal Serum Zinc, Cord Blood Osteocalcin and Neonatal Birth Length
Zinc Supplementation During Pregnancy for the Prevention of Stunting: Analysis of Maternal Serum Zinc, Cord Blood Osteocalcin and Neonatal Birth Length
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sumatera Utara
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Medan, Sumatera Utara, Indonesia, 20155
- Universitas Sumatera Utara
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Zinc Supplementation Group
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.
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Enrolled subjects received zinc capsule 20mg daily in the morning after meal for 12 weeks
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Comparador de placebos: Placebo Group
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
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Zinc Supplementation During Pregnancy Prevent Stunting Occurence to the Newborn: Analysis of Maternal Serum Zinc, Cord Blood Osteocalcin and Neonatal Birth Length
Periodo de tiempo: 12 weeks up to childbirth
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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
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12 weeks up to childbirth
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Correlation Between Maternal Zinc Supplementation with Maternal Serum Zinc Levels
Periodo de tiempo: 12 weeks
|
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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lili Rohmawati, Researcher, Universitas Sumatera Utara
Publicaciones y enlaces útiles
Publicaciones Generales
- 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 9/UN5.2.3.1/PPM/KP-DRPM/2019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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