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

16 de septiembre de 2020 actualizado por: Lili Rohmawati, Universitas Sumatera Utara

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.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

71

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Sumatera Utara
      • Medan, Sumatera Utara, Indonesia, 20155
        • Universitas Sumatera Utara

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 35 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

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

¿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
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

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Lili Rohmawati, Researcher, Universitas Sumatera Utara

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2019

Finalización primaria (Actual)

1 de diciembre de 2019

Finalización del estudio (Actual)

30 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2020

Publicado por primera vez (Actual)

22 de septiembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2020

Última verificación

1 de septiembre de 2020

Más información

Términos relacionados con este estudio

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

The results of this study

Marco de tiempo para compartir IPD

Agustus 2020

Criterios de acceso compartido de IPD

lily_rahmawati234@yahoo.com

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.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Deficiencia de zinc

Ensayos clínicos sobre Zinc Supplementation Group

3
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