Fish Oil and Folate Supplementation During Pregnancy (NUHEAL)

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Perinatal DHA and Folate Status; Neurological Development

Treatments: Dietary Supplement: folate; Dietary Supplement: placebo; Dietary Supplement: fish oil + folate; Dietary Supplement: fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01180933

01111

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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315 participants in 4 patient groups, including a placebo group

fish oil

Experimental group

Description:

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

Treatment:

Dietary Supplement: fish oil

folate

Experimental group

Description:

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

Treatment:

Dietary Supplement: folate

fish oil + folate

Experimental group

Description:

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

Treatment:

Dietary Supplement: fish oil + folate

placebo

Placebo Comparator group

Description:

the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery

Treatment:

Dietary Supplement: placebo