NUHEAL: Fish Oil and Folate Supplementation During Pregnancy

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT01180933

Collaborator

European Union (Other)

315

Enrollment

Locations

Arms

136

Duration (Months)

105

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood.

Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.

Condition or Disease	Intervention/Treatment	Phase
Perinatal DHA and Folate Status Neurological Development	Dietary Supplement: fish oil Dietary Supplement: folate Dietary Supplement: fish oil + folate Dietary Supplement: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

315 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy

Study Start Date :

Nov 1, 2001

Actual Primary Completion Date :

Aug 1, 2003

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fish oil the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA and 150 eicosapentaenoic acid per day from gestational week 22 until delivery	Dietary Supplement: fish oil 400 mg of DHA and 150 mg of eicosapentaenoic acid per day
Experimental: folate the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 400 µg folate (methyltetrahydrofolate)per day from gestational week 22 until delivery	Dietary Supplement: folate 400 µg per day
Experimental: fish oil + folate the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA, 150 mg eicosapentaenoic acid and 400 µg MTHF per day from gestational week 22 until delivery	Dietary Supplement: fish oil + folate 500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
Placebo Comparator: placebo the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery	Dietary Supplement: placebo only vitamins and minerals as recommended, but no fish oil or folate

Outcome Measures

Primary Outcome Measures

percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood [labour]
the biochemical efficacy of supplementation during pregnancy is tested by measuring the DHA content of cord blood phospholipids, as direct supplementation (fish oil) or increased perfusion of the placenta (MTHF) could both influence this parameter

Secondary Outcome Measures

neurological and cognitive development of the offspring [age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years]
non invasive, age adequate, tests of neurological and cognitive function are performed at various ages of the offspring
weight development [age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years]
body weight (including weight of fat and non fat mass by bioelectrical impedance at later ages) is determined
height [age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years]
body height is measured at ages 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years
life style and diet [age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years]
information on medical history, life sytyle and dietary habits is collected via questionnaires and non invasivly collected of biological samples (urine, cheek cells)
electroencephalography (EEG) [age 8 years and 9.5 years]
at age 8 years and 9.5 years an EEG is obtained while the children are performing defined tests

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 41 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

singleton pregnancy
gestation <20 week at enrollment
intention to deliver in one of the study centers
body weight at time of enrollment from 50 kg to 92 kg

Exclusion Criteria:

serious chronic illness (eg, diabetes, hepatitis)
use fish oil supplements since the beginning of pregnancy
use of folate or vitamin B-12 supplements after gestation week 16

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University	Munich	Germany	80337
2	University of Pecs	Pecs	Hungary	7623
3	Department of Paediatrics, University of Granada	Granada	Spain	18012