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

This study has been withdrawn prior to enrollment.
(decision made not to proceed -- no subjects were ever enrolled)
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00691418
First received: June 3, 2008
Last updated: August 5, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention
Premature Birth
Dietary Supplement: docosahexaenoic acid (DHA)
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DHA Administration and Length of Gestation: a Feasibility Study

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

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? [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
600 mg per day of docosahexaenoic acid (DHA)
Dietary Supplement: docosahexaenoic acid (DHA)
600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.
Other Name: omega fatty acid
Placebo Comparator: 2
Placebo
Dietary Supplement: placebo
placebo once per day starting at 22-24 weeks gestation until 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691418

Sponsors and Collaborators
Kaiser Permanente
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Gabriel Escobar, MD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Gabriel Escobar, MD, Principal Investigator, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00691418     History of Changes
Other Study ID Numbers: KP-Martek01
Study First Received: June 3, 2008
Last Updated: August 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
perinatal
premature
pregnancy
gestation

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 21, 2014