Prenatal Multi-micronutrient Supplementation and Pregnancy Outcome

This study has been completed.
Sponsor:
Collaborator:
Royal Veterinary and Agricultural University, Denmark
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00168688
First received: September 13, 2005
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Pregnancy
Birth Weight
Dietary Supplement: multi micronutrient supplement
Dietary Supplement: MN1
Dietary Supplement: MN2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Birth weight (<3 days)
  • Perinatal mortality

Secondary Outcome Measures:
  • Maternal haemoglobin (8 weeks pp)
  • Maternal anthropometry (8 weeks pp)
  • Infant growth (8 weeks pp)

Enrollment: 2100
Study Start Date: January 2001
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FeFol
Iron (60 mg) and folic acid (400 ug), standard of care
Dietary Supplement: multi micronutrient supplement
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

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
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

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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women

Exclusion Criteria:

  • >37 weeks of gestational at enrollment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00168688

Locations
Guinea-Bissau
Bandim Health Project
Bissau, Guinea-Bissau, Apartado 861
Sponsors and Collaborators
Bandim Health Project
Royal Veterinary and Agricultural University, Denmark
Investigators
Study Director: Peter Aaby, Dr. Med Bandim Health Project
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00168688     History of Changes
Other Study ID Numbers: RUF-2001-91057-PREGNUT
Study First Received: September 13, 2005
Last Updated: November 15, 2013
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
micronutrient supplementation
pregnancy
birth weight
perinatal mortality

Additional relevant MeSH terms:
Vitamin B Complex
Birth Weight
Body Weight
Signs and Symptoms
Vitamin B 12
Micronutrients
Trace Elements
Vitamins
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014