Investigation of DHA Intake in Pregnant and Lactating Women in China
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To evaluate the feasibility in using DHA Screener for determination of internal DHA concentration
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
Periodo de tiempo: 5 months
|
|
5 months
|
|
To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.
Periodo de tiempo: 5 months
|
To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.
|
5 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women
Periodo de tiempo: 5 months
|
To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women
|
5 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Jianmeng Liu, Doctor, Peking University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 14.10.CN.INF
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