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

NCT ID: NCT00691418

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-08-31

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.

Conditions

Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

600 mg per day of docosahexaenoic acid (DHA)

Group Type: ACTIVE_COMPARATOR

docosahexaenoic acid (DHA)

Intervention Type: DIETARY_SUPPLEMENT

600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.

2

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo once per day starting at 22-24 weeks gestation until delivery.

Interventions

docosahexaenoic acid (DHA)

600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.

Intervention Type: DIETARY_SUPPLEMENT

placebo

placebo once per day starting at 22-24 weeks gestation until delivery.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

omega fatty acid

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Escobar, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Other Identifiers

KP-Martek01

Identifier Type: -

Identifier Source: org_study_id