MedDataX Logo

Prenatal Multi-micronutrient Supplementation and Pregnancy Outcome

NCT ID: NCT00168688

Last Updated: 2013-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

2100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 A) Iron + folic acid or multi-micronutrients in B) One or C) Two recommended dietary allowances. Secondary outcomes were infant growth and maternal haemoglobin eight weeks after delivery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Birth Weight

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

micronutrient supplementation pregnancy birth weight perinatal mortality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FeFol

Iron (60 mg) and folic acid (400 ug), standard of care

Group Type ACTIVE_COMPARATOR

multi micronutrient supplement

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

MN1

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

MN2

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

multi micronutrient supplement

Intervention Type DIETARY_SUPPLEMENT

MN1

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

Intervention Type DIETARY_SUPPLEMENT

MN2

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant women

Exclusion Criteria

* \>37 weeks of gestational at enrollment
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Royal Veterinary and Agricultural University, Denmark

OTHER

Sponsor Role collaborator

Bandim Health Project

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Aaby, Dr. Med

Role: STUDY_DIRECTOR

Bandim Health Project

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bandim Health Project

Bissau, , Guinea-Bissau

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Guinea-Bissau

References

Explore related publications, articles, or registry entries linked to this study.

Kaestel P, Michaelsen KF, Aaby P, Friis H. Effects of prenatal multimicronutrient supplements on birth weight and perinatal mortality: a randomised, controlled trial in Guinea-Bissau. Eur J Clin Nutr. 2005 Sep;59(9):1081-9. doi: 10.1038/sj.ejcn.1602215.

Reference Type RESULT
PMID: 16015266 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RUF-2001-91057-PREGNUT

Identifier Type: -

Identifier Source: org_study_id