- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Sumatera Utara
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Medan, Sumatera Utara, 인도네시아, 20155
- Universitas Sumatera Utara
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Zinc Supplementation During Pregnancy Prevent Stunting Occurence to the Newborn: Analysis of Maternal Serum Zinc, Cord Blood Osteocalcin and Neonatal Birth Length
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Correlation Between Maternal Zinc Supplementation with Maternal Serum Zinc Levels
기간: 12 weeks
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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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공동 작업자 및 조사자
수사관
- 수석 연구원: Lili Rohmawati, Researcher, Universitas Sumatera Utara
간행물 및 유용한 링크
일반 간행물
- 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
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 9/UN5.2.3.1/PPM/KP-DRPM/2019
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 정보에 입각한 동의서(ICF)
- 임상 연구 보고서(CSR)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
아연 결핍에 대한 임상 시험
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