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Withdrawn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

About this trial
This is an interventional prevention trial for Premature Birth focused on measuring perinatal, premature, pregnancy, gestation
Eligibility Criteria
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
NCT ID
NCT00691418
First Posted
June 3, 2008
Last Updated
March 4, 2015
Sponsor
Kaiser Permanente
Collaborators
DSM Nutritional Products, Inc.
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Withdrawn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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