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Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study

Primary Purpose

Premature Birth

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
docosahexaenoic acid (DHA)
placebo
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring perinatal, premature, pregnancy, gestation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Previous preterm delivery (delivery prior to 37 completed weeks of gestation)

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    600 mg per day of docosahexaenoic acid (DHA)

    Placebo

    Outcomes

    Primary Outcome Measures

    Is daily intake of 600 mg per day of docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid, beginning at 22-24 weeks gestation, associated with increased length of gestation among women who have had a previous preterm delivery?

    Secondary Outcome Measures

    Full Information

    First Posted
    June 3, 2008
    Last Updated
    March 4, 2015
    Sponsor
    Kaiser Permanente
    Collaborators
    DSM Nutritional Products, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00691418
    Brief Title
    Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study
    Official Title
    DHA Administration and Length of Gestation: a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    decision made not to proceed -- no subjects were ever enrolled
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaiser Permanente
    Collaborators
    DSM Nutritional Products, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a feasibility study to determine if it will be possible to conduct a larger study of the effect of docosahexaenoic acid (DHA), an omega fatty acid, on increased length of gestation among women who have had a previous preterm delivery.
    Detailed Description
    We propose to conduct an 18-month feasibility study to determine (a) how many women we could approach during a 4-month period, (b) how many of these women would be eligible for a future RCT, (c) how many would consent to participate in the RCT, and (d) how many would be subsequently rendered ineligible due to poor compliance. Women enrolled during the 4-month recruitment period would be followed until 1 month after delivery using telephone contact (for assessing compliance) and scanning of KPMCP electronic databases (for quantifying outcomes). We hope to enroll 50 to 75 women during our fixed time (4 months) recruitment period. Half of these 50-75 women would receive DHA; half would receive placebo. We will identify potential subjects based on their response to the Preterm Birth Prevention Program questionnaire (a screening instrument administered by the Regional Perinatal Service Center [RPSC] to all women in the KPMCP entering prenatal care). Eligible women are those pregnant women entering prenatal care who, based on their response to the abovementioned RPSC questionnaire, are identified as having had a previous preterm delivery (delivery prior to 37 completed weeks of gestation). Results of this study will (a) permit us to determine whether an RCT is feasible at a reasonable cost, and (b) assuming the answer to (a) is positive, it would then be possible for us to design an RCT that could address our primary study question.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Birth
    Keywords
    perinatal, premature, pregnancy, gestation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    600 mg per day of docosahexaenoic acid (DHA)
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    docosahexaenoic acid (DHA)
    Other Intervention Name(s)
    omega fatty acid
    Intervention Description
    600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    placebo once per day starting at 22-24 weeks gestation until delivery.
    Primary Outcome Measure Information:
    Title
    Is daily intake of 600 mg per day of docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid, beginning at 22-24 weeks gestation, associated with increased length of gestation among women who have had a previous preterm delivery?
    Time Frame
    18 months

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Previous preterm delivery (delivery prior to 37 completed weeks of gestation) Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gabriel Escobar, MD
    Organizational Affiliation
    Kaiser Permanente
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study

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