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Investigation of DHA Intake in Pregnant and Lactating Women in China

1 december 2014 uppdaterad av: Liu Jianmeng, Peking University
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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

1254

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 40 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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)

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To evaluate the feasibility in using DHA Screener for determination of internal DHA concentration
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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.
5 months
To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.
Tidsram: 5 months
To compare DHA intake assessed by DHA Screener against Chinese recommendations of DHA intake.
5 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women
Tidsram: 5 months
To assess the correlation between DHA intake and DHA concentrations in the blood and breast milk of lactating women
5 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Peking University

Utredare

  • Studiestol: Jianmeng Liu, Doctor, Peking University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2014

Primärt slutförande (Faktisk)

1 oktober 2014

Avslutad studie (Faktisk)

1 oktober 2014

Studieregistreringsdatum

Först inskickad

1 april 2014

Först inskickad som uppfyllde QC-kriterierna

1 april 2014

Första postat (Uppskatta)

4 april 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

2 december 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 december 2014

Senast verifierad

1 december 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 14.10.CN.INF

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