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Investigation of DHA Intake in Pregnant and Lactating Women in China

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ClinicalTrials.gov Identifier: NCT02104544
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Liu Jianmeng, Peking University

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.

Condition or disease
Nutrient Intake Disorder

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.


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Study Type : Observational
Actual Enrollment : 1254 participants
Observational Model: Cohort
Official Title: Investigation of DHA Intake in Pregnant and Lactating Women in China
Study Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014



Primary Outcome Measures :
  1. To evaluate the feasibility in using DHA Screener for determination of internal DHA concentration [ Time Frame: 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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 5 months ]
    1. To assess correlation between DHA Screener assessment tool and RBC DHA among study groups;
    2. To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.

  2. To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake. [ Time Frame: 5 months ]
    To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.


Other Outcome Measures:
  1. To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women [ Time Frame: 5 months ]
    To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women


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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104544


Sponsors and Collaborators
Peking University
Investigators
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Study Chair: Jianmeng Liu, Doctor Peking University

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Responsible Party: Liu Jianmeng, The Institute of Reproductive and Child Health, Peking University
ClinicalTrials.gov Identifier: NCT02104544     History of Changes
Other Study ID Numbers: 14.10.CN.INF
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014
Keywords provided by Liu Jianmeng, Peking University:
DHA intake;
Plasma;
Erythrocyte;
Breast milk.