Investigation of DHA Intake in Pregnant and Lactating Women in China
연구 개요
상태
정황
상세 설명
This is a multi-center, cross-sectional, non-interventional, observational study in 816 pregnant (gestation week 17±2 group and gestation week 39±2 group 408 cases in each group) and 408 lactating women (post-natal lactation day 42±7 group) from a total of 4 sites in 3 typical areas (1 coastal regions, 2 inland regions and 1 lake regions) in China to study the correlation between DHA intake and DHA concentrations in blood and breast milk. Investigators are mainly physicians majoring in gynaecology and obstetrics, etc. During visits, the study physician will record the patient's social demographic data, disease and relevant medication history, review her medical records, assess DHA intake by the DHA Screener, and determine DHA concentrations in erythrocyte membrane, plasma and breast milk, so as to validate the feasibility of DHA Screener as DHA intake assessment tool for determining DHA concentrations in the body.
Subjects meeting inclusion criteria and non of the exclusion criteria will be informed of relevant information of the study. Subjects should be voluntarily consent to participate in the study and sign the informed consent form.
Screening of the study is scheduled for as long as 5 months. In this study, additional examinations or other interventions are not required.
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
PREGNANT WOMEN:
- Healthy women presenting at their week 17±2 and week 39±2 obstetric examination;
- 18-40 years of age;
- Monocyesis;
- Having signed the informed consent form voluntarity before participating in the study.
LACTATING WOMEN:
- Healthy women presenting at their day 42±7 post-natal visit;
- 18-40 years of age;
- Monocyesis;
- Having signed the informed consent form voluntarily before participating in the study
Exclusion Criteria:
- Administration of DHA supplements (milk powder for pregnant women, DHA soft capsule, Zmarto, NURIZ, Naturies, HeadDHA, Beibeicong, Nutrimed etc);
- Still experiencing severe vomiting after 16 weeks of pregnancy;
- Women who have heart, liver, kidney, (ALT and AST≥ 1.5 times of normal upper limit, Cr>normal upper limit) or severe lung disease or laboratory abnormality (i.e.lipid metabolism disorder) that may interfere with the interpretation of study results, as indicated in previous examinations;
- Pregnant woman currently participating in other clinical trials or who have participated in another clinical trial in the last 30 days;
- Women who in the judgement of the investigator cannot be expected to comply with the protocol or study procedures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To evaluate the feasibility in using DHA Screener for determination of internal DHA concentration
기간: 5 months
|
Correlation between DHA Screener and DHA concentration in plasma; Correlation between DHA Screener and DHA concentration in erythrocyte membrane; Correlation between DHA Screener and DHA concentration in breast milk.
|
5 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To compare the correlation between DHA Screener and RBC DHA among different subgroups. To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.
기간: 5 months
|
|
5 months
|
|
To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.
기간: 5 months
|
To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.
|
5 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women
기간: 5 months
|
To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women
|
5 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: Jianmeng Liu, Doctor, Peking University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 14.10.CN.INF
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