- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168688
Prenatal Multi-micronutrient Supplementation and Pregnancy Outcome
The Effects of Prenatal Multi-micronutrient Supplements on Pregnancy Outcome, Peri- and Neonatal Mortality on Maternal and Infant Nutritional Status: A Randomised, Controlled Trial Among Women in Guinea-Bissau
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prenatal maternal micronutrient supplementation has been suggested as a means to reduce the proportion of low birth weight babies in low-income countries. The effects of prenatal multi-micronutrient supplements on birth weight and perinatal mortality were studied in a randomised controlled trial among 2100 pregnant women in Guinea-Bissau. Women up to 37 weeks pregnant were individually randomised to daily supplements until delivery of identically looking tablets containing 1) Iron (60 mg) + folate (400 µg), 2) One recommended dietary allowance (RDA) of 5 minerals and 10 vitamins, including iron (30 mg) and folate (400 µg), or 3) Two RDA's of 5 minerals and 10 vitamins, including iron (30 mg) and folate (800 µg). Supplements were provided in known excess at fortnightly home visits until delivery. Compliance was assessed by tablet count.
Women were interviewed about age, civil status, obstetric history and socio-economic status at enrolment. Maternal anthropometry was measured at enrolment, at delivery, and eight weeks after delivery. Maternal malaria parasitaemia and haemoglobin were measured at enrolment and eight weeks after delivery. Maternal status of a wide range of micronutrients was assessed at enrolment and eight weeks after delivery in a sub-cohort of 600 women. Further, survival of the infants will be followed until 3 years of age, within the routines of the Bandim Health Project surveillance system.
Women were provided impregnated bed nets and weekly malaria prophylaxis until delivery. Women with high malaria parasitaemia at enrolment were in addition given a full treatment at enrolment.
Sample size considerations: A sample size of 638 women in each treatment group will be required to detect a reduction in perinatal mortality from 9% to 5% or less in a treatment group using 80% power and a 5% significance level. With an expected loss to follow up of 10%, 2100 women are required. With a sample size of 2100 the study will be able to detect at least 75 g difference, i.e. a 2.5% change in birth weight.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Bissau, Guinea-Bissau, Apartado 861
- Bandim Health Project
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant women
Exclusion Criteria:
- >37 weeks of gestational at enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: FeFol
Iron (60 mg) and folic acid (400 ug), standard of care
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|
Experimental: MN1
1 RDA of 15 micronutrients, including iron (30 mg) and folic acid (400 ug) Vitamin A 800 μg RE, Vitamin D 200 IU, Vitamin E 10 mg, Vitamin B1 1.4 mg, Vitamin B2 1.4 mg, Niacin 18 mg, Folic acid 400 μg, Vitamin B6 1.9 mg, Vitamin B12 2.6 μg, Vitamin C 70 mg, Zinc 15 mg, Iron 30 mg, Copper 2.0 mg, Selenium 65 μg, Iodine 150 μg |
Vitamin A 800 μg RE, Vitamin D 200 IU, Vitamin E 10 mg, Vitamin B1 1.4 mg, Vitamin B2 1.4 mg, Niacin 18 mg, Folic acid 400 μg, Vitamin B6 1.9 mg, Vitamin B12 2.6 μg, Vitamin C 70 mg, Zinc 15 mg, Iron 30 mg, Copper 2.0 mg, Selenium 65 μg, Iodine 150 μg
|
Experimental: MN2
2 RDA of 14 micronutrients including iron (30 mg) and folic acid (800 ug) Vitamin A 1600 μg RE, Vitamin D 400 IU, Vitamin E 20 mg, Vitamin B1 2.8 mg, Vitamin B2 2.8 mg, Niacin 36 mg, Folic acid 800 μg, Vitamin B6 3.8 mg, Vitamin B12 5.2 μg, Vitamin C 140 mg, Zinc 30 mg, Iron 30 mg, Copper 4.0 mg, Selenium 130 μg, Iodine 300 μg |
Vitamin A 1600 μg RE, Vitamin D 400 IU, Vitamin E 20 mg, Vitamin B1 2.8 mg, Vitamin B2 2.8 mg, Niacin 36 mg, Folic acid 800 μg, Vitamin B6 3.8 mg, Vitamin B12 5.2 μg, Vitamin C 140 mg, Zinc 30 mg, Iron 30 mg, Copper 4.0 mg, Selenium 130 μg, Iodine 300 μg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Birth weight (<3 days)
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Perinatal mortality
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Secondary Outcome Measures
Outcome Measure |
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Maternal haemoglobin (8 weeks pp)
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Maternal anthropometry (8 weeks pp)
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Infant growth (8 weeks pp)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Peter Aaby, Dr. Med, Bandim Health Project
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RUF-2001-91057-PREGNUT
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