Clinical trial NCT02104544: Investigation of DHA Intake in Pregnant and Lactating Women in China
Official title: Investigation of DHA Intake in Pregnant and Lactating Women in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrient Intake Disorder
Keywords: DHA intake;
Plasma;
Erythrocyte;
Breast milk.
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 1254
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 816 pregnant (pregnant week 17±2 group and pregnant week 39±2 group; 408 cases in each group) and 408 lactating women (post-natal lactation day 42±7 group)

Brief summary: This is a multi-center, cross-sectional, non-interventional, observational study--an investigation carried out in 816 pregnant (pregnant week 17±2 group and pregnant 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the feasibility in using DHA Screener for determination of internal DHA concentration
timeFrame: 5 months
Secondary outcomes:
measure: 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.
timeFrame: 5 months
measure: To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.
timeFrame: 5 months
Other outcomes:
measure: To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women
timeFrame: 5 months
Locations:
Study officials:
affiliation: Peking University
name: Jianmeng Liu, Doctor
role: STUDY_CHAIR
References: