Investigation of DHA Intake in Pregnant and Lactating Women in China

Nutrient Intake Disorder Clinical Trial

Official title:

Investigation of DHA Intake in Pregnant and Lactating Women in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104544
• Other study ID #: 14.10.CN.INF
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: December 1, 2014
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1254
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Eating Disorders
• Nutrient Intake Disorder
• Nutrition Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women	To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women	5 months	No
Primary	To evaluate the feasibility in using DHA Screener for determination of internal DHA concentration	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	No
Secondary	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.	To assess correlation between DHA Screener assessment tool and RBC DHA among study groups; To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.	5 months	No
Secondary	To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.	To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.	5 months	No