Investigation of DHA Intake in Pregnant and Lactating Women in China

NCT02104544 | Completed DMC

• 1 other identifier: 14.10.CN.INF
• Study Type: observational
• Target: 1,254
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nutrient Intake Disorder

Keywords

DHA intake;; Plasma;; Erythrocyte;; Breast milk.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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.

  5 months

• To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.

  5 months

Other Outcomes (1)

• To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women

  5 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• PREGNANT WOMEN:
• Healthy women presenting at their week 17±2 and week 39±2 obstetric examination;
• 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;
• years of age;
• Monocyesis;
• Having signed the informed consent form voluntarily before participating in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Collection of venous blood, pretreatment of blood sample, take the plasma and erythrocyte respectively. 2. Collection of breast milk (only for women having lactated for 42±7 days)

Study Officials

• Jianmeng Liu, Doctor

  Peking University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Institute of Reproductive and Child Health

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12