Prenatal Multi-micronutrient Supplementation and Pregnancy Outcome

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168688
• Other study ID #: RUF-2001-91057-PREGNUT
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: November 15, 2013
• Start date: January 2001
• Est. completion date: October 2002

Study information

• Verified date: November 2013
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2100
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women

Exclusion Criteria:

• >37 weeks of gestational at enrollment

Study Design

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

Related Conditions & MeSH terms

• Birth Weight
• Pregnancy

Intervention

Dietary Supplement:
• multi micronutrient 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
• 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

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau

Sponsors (2)

Lead Sponsor	Collaborator
Bandim Health Project	Royal Veterinary and Agricultural University, Denmark

Country where clinical trial is conducted

Guinea-Bissau, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight (<3 days)
Primary	Perinatal mortality
Secondary	Maternal haemoglobin (8 weeks pp)
Secondary	Maternal anthropometry (8 weeks pp)
Secondary	Infant growth (8 weeks pp)