Trial Outcomes & Findings for Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes (NCT NCT01007110)

NCT ID: NCT01007110

Last Updated: 2014-06-09

Results Overview

Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 67 participants
• Primary outcome timeframe: 24, 32 and 36 weeks gestational age
• Results posted on: 2014-06-09

Participant Flow

Participant milestones

Measure	Placebo soy/corn oil placebo	Docosahexaenoic Acid (DHA) 600 mg Docosahexaenoic Acid (DHA)
Allocation STARTED	32	35
Allocation COMPLETED	25	27
Allocation NOT COMPLETED	7	8
Follow-Up at 24 Weeks STARTED	25	27
Follow-Up at 24 Weeks COMPLETED	25	23
Follow-Up at 24 Weeks NOT COMPLETED	0	4
Follow-Up at 32 Weeks STARTED	25	23
Follow-Up at 32 Weeks COMPLETED	24	22
Follow-Up at 32 Weeks NOT COMPLETED	1	1
Follow-Up at 36 Weeks STARTED	24	22
Follow-Up at 36 Weeks COMPLETED	24	20
Follow-Up at 36 Weeks NOT COMPLETED	0	2
Neonatal Behavioral Assessment Scale (NB STARTED	24	20
Neonatal Behavioral Assessment Scale (NB COMPLETED	12	15
Neonatal Behavioral Assessment Scale (NB NOT COMPLETED	12	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

Baseline characteristics by cohort

Measure	Placebo n=32 Participants soy/corn oil placebo	Docosahexaenoic Acid (DHA) n=35 Participants 600 mg Docosahexaenoic Acid (DHA)	Total n=67 Participants Total of all reporting groups
Age, Continuous	25.6 years STANDARD_DEVIATION 4.8 • n=5 Participants	25.5 years STANDARD_DEVIATION 4.3 • n=7 Participants	25.5 years STANDARD_DEVIATION 4.51 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	35 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	35 participants n=7 Participants	67 participants n=5 Participants
Enrollment BMI	29.0 kg/m^2 STANDARD_DEVIATION 7.0 • n=5 Participants	26.8 kg/m^2 STANDARD_DEVIATION 5.5 • n=7 Participants	27.9 kg/m^2 STANDARD_DEVIATION 6.21 • n=5 Participants
Education	13.9 Years STANDARD_DEVIATION 2.7 • n=5 Participants	14.0 Years STANDARD_DEVIATION 3.1 • n=7 Participants	14 Years STANDARD_DEVIATION 2.89 • n=5 Participants
Gestational Age (GA)	15.2 Weeks STANDARD_DEVIATION 3.7 • n=5 Participants	13.6 Weeks STANDARD_DEVIATION 4.1 • n=7 Participants	14.4 Weeks STANDARD_DEVIATION 3.88 • n=5 Participants

PRIMARY outcome

Timeframe: 24, 32 and 36 weeks gestational age

Population: Placebo: 19 subjects @ 24 wks GA, 25 subjects @ 32 wks GA, 24 subjects @ 36 wks GA DHA: 21 subjects @ 24 wks GA, 23 subjects @ 32 wks GA, 22 subjects @ 36 wks GA

Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.

Outcome measures

Measure	Placebo n=25 Participants soy/corn oil placebo	Docosahexaenoic Acid (DHA) n=23 Participants 600 mg/day docosahexaenoic acid (DHA)
Heart Rate Heart Rate 24 weeks Gestational Age	146.0 Beats per minute Standard Deviation 6.5	145.2 Beats per minute Standard Deviation 6.8
Heart Rate Heart Rate 32 weeks Gestational Age	142.5 Beats per minute Standard Deviation 7.7	140.8 Beats per minute Standard Deviation 7.6
Heart Rate Heart Rate 36 weeks Gestational Age	145.0 Beats per minute Standard Deviation 8.6	141.7 Beats per minute Standard Deviation 9.3

SECONDARY outcome

Timeframe: within 2 weeks of delivery

The Neonatal Behavioral Assessment Scale (NBAS) measure 6 areas.

For behavioral items a higher score corresponds to more desirable outcomes:

1. Habituation: Sum of scores across 3 items, scored on a scale of 1-9. Range: 3-27.

2. Orientation: Sum of scores across 7 items, scored on a scale of 1-9. Range: 7 - 63.

3. Motor: Sum of scores across 5 items; 3 scored on a scale of 1-9, 1 scored on a scale of 1-6, and 1 scored on a scale of 1-5. Range: 5-38.

4. Range of State: Sum of scores across 4 items; 2 scored on a scale of 1-6 and 2 scored on a scale of 1-5. Range: 4-22.

5. Regulation of State: Sum of scores across 4 items, scored on a scale of 1-9. Range: is 4-36.

6. Autonomic Stability: Sum of scores across 3 items; 1 scored on a scale of 1-9, 1 on a scale of 1-8, and 1 on a scale of 1-6. Range: 3-23.

Reflexes: Sum across the 18 items, scored on a scale of 0-3. Range: 0 to 54. The supplementary items are each scored on a scale of 1-9 and do not combine to form a composite.

Outcome measures

Measure	Placebo n=12 Participants soy/corn oil placebo	Docosahexaenoic Acid (DHA) n=15 Participants 600 mg/day docosahexaenoic acid (DHA)
Neonatal Behavioral Assessment Scale (NBAS) Scores Habituation	9.92 units on a scale Standard Deviation 9.28	8.47 units on a scale Standard Deviation 9.26
Neonatal Behavioral Assessment Scale (NBAS) Scores Orienting	19.75 units on a scale Standard Deviation 15.45	23.40 units on a scale Standard Deviation 18.32
Neonatal Behavioral Assessment Scale (NBAS) Scores Motor	23.08 units on a scale Standard Deviation 11.40	26.07 units on a scale Standard Deviation 18.13
Neonatal Behavioral Assessment Scale (NBAS) Scores State Organization	13.50 units on a scale Standard Deviation 13.89	15.13 units on a scale Standard Deviation 8.02
Neonatal Behavioral Assessment Scale (NBAS) Scores State Regulation	16.42 units on a scale Standard Deviation 20.02	16.93 units on a scale Standard Deviation 20.06
Neonatal Behavioral Assessment Scale (NBAS) Scores Autonomic	14.83 units on a scale Standard Deviation 16.90	18.13 units on a scale Standard Deviation 14.48
Neonatal Behavioral Assessment Scale (NBAS) Scores Reflexes	21.92 units on a scale Standard Deviation 14.45	22.60 units on a scale Standard Deviation 14.33

SECONDARY outcome

Timeframe: Time of delivery, 36 weeks to term

Maternal red blood cell phospholipid collected at delivery. These results were compared to baseline red blood cell phospholipid that was collected at study enrollment. A weighed standard fatty acid mixture (Supelco 37 component fatty acid methyl ester mix,Sigma Aldrich) was employed to correct final DHA weight percent of total fatty acids (wt%TFA).

Outcome measures

Measure	Placebo n=24 Participants soy/corn oil placebo	Docosahexaenoic Acid (DHA) n=22 Participants 600 mg/day docosahexaenoic acid (DHA)
Maternal Red Blood Cell (RBC) Phospholipids at Delivery	4.99 weight percent Total Fatty Acids Interval 4.42 to 5.69	7.09 weight percent Total Fatty Acids Interval 5.39 to 10.3

SECONDARY outcome

Timeframe: Birth

Newborn red blood cell phospholipids collected at birth.

Outcome measures

Measure	Placebo n=24 Participants soy/corn oil placebo	Docosahexaenoic Acid (DHA) n=22 Participants 600 mg/day docosahexaenoic acid (DHA)
Cord Blood Phospholipids DHA	6.18 weight percent total fatty acids Interval 5.81 to 6.87	7.75 weight percent total fatty acids Interval 6.01 to 9.03

SECONDARY outcome

Timeframe: Change from Baseline to 2 Months Post-natal

Outcome measures

Measure	Placebo n=24 Participants soy/corn oil placebo	Docosahexaenoic Acid (DHA) n=22 Participants 600 mg/day docosahexaenoic acid (DHA)
Cardiac Conduction Time	38.98 milliseconds Standard Deviation 3.62	39.49 milliseconds Standard Deviation 2.798

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Docosahexaenoic Acid (DHA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Gustafson, Ph.D.

University of Kansas Medical Center

Phone: (913) 588-0065

Email: kgustafson@kumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place