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Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso (MISAME2)

This study has been completed.
Sponsor:
Collaborators:
University Ghent
Flemish Interuniversity Council (VLIR)
Nutrition Third World
Information provided by:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT00909974
First received: May 28, 2009
Last updated: September 12, 2010
Last verified: September 2010
  Purpose

Low birth weight (LBW; birth weight<2,500g) is the most important determinant of mortality and morbidity in the neonatal period. It is also a very important factor in predicting nutritional status, health and development in childhood. It even influences health in adult life, contributing to the vicious cycle of disease and poverty. The high rate LBW in DCs represents therefore a major public health problem. Maternal chronic energy deficiency is assumed to be a major determinant of the problem in these countries along with prenatal micronutrient deficiencies. A large body of recent evidence points out that multiple micronutrient supplementation as such has only a modest beneficial effect on fetal growth. Therefore, it is expected that providing these multiple micronutrients in a food supplement covering energy requirement needs of pregnant women will have an effect of public health importance on children's health.

This study has the objective of improving children's health by improving birth outcome and fetal growth through the provision of a food supplement enriched in multimicronutrients during pregnancy.

This research includes 2 constituents:

  1. a pilot phase during which dietary behavior of pregnant women is assessed as a component for optimal fetal growth
  2. a randomized, placebo-controlled trial, including 1300 pregnant women aimed at testing 2 hypotheses: supplementing pregnant women with a food supplement containing a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy.

The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz, which plays a leader role in research and services providing at the district level and in policy recommendations at the national level. This will ensure that the study findings are incorporated into on-going district programs with possible replication at the national level. The research lasts from February 2006 to August 2009.


Condition Intervention Phase
Intrauterine Growth Retardation
Low Birth Weight
Dietary Supplement: UNIMMAP - multiple micronutrients
Dietary Supplement: Food supplement enriched with multiple micronutrients
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
  • Mortality, morbidity and growth during the first year of life [ Time Frame: Monthly during infancy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Placental weight; LBW; SGA; thoracic circumference; head circumference; mid-upper arm circumference; hemoglobin concentration in mothers and in newborns; soluble sTfR in cord blood as an iron status indicator; preterm birth; stillbirth; perinatal death [ Time Frame: Different depending on mother and child ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1302
Study Start Date: February 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Food supplement (FS)
Recipe of food supplement: 33% peanut butter, 32% soy flour, 15% vegetable oil, 20% sugar, UNIMMAP in powdered form Nutritional composition (per dose of 72g) Energy 1.56 MJ, protein 14.7 g, vitamin A 881 µg, vitamin E 13 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 21 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 461 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg
Dietary Supplement: Food supplement enriched with multiple micronutrients

One dose of 72g per day during whole pregnancy

Recipe of food supplement: 33% peanut butter, 32% soy flour, 15% vegetable oil, 20% sugar, UNIMMAP in powdered form Nutritional composition (per dose of 72g) Energy 1.56 MJ, protein 14.7 g, vitamin A 881 µg, vitamin E 13 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 21 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 461 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg

Other Name: Lipid based nutritional supplement (LNS)
Active Comparator: UNIMMAP
UNIMMAPin tablet form: vitamin A 800µg, vitamin E 10 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 18 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 400 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg
Dietary Supplement: UNIMMAP - multiple micronutrients

Daily supplementation of one UNIMMAP tablet

multiple micronutrient supplements (MMN): UNIMMAP: vitamin A 800µg, vitamin E 10 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 18 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 400 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All the women of child-bearing age (15-44 years) living in the study area (4 100) will be visited monthly to assess early pregnancy and will be invited to participate in the trial.

Exclusion Criteria:

  • planning to move outside the district within the 2 years following the start of the trial.
  • regularly using a contraceptive method.
  • already pregnant at the start of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909974

Locations
Burkina Faso
Centre Muraz, 2054, Avenue Mamadou KONATE
Bobo-Dioulasso, Burkina Faso
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
University Ghent
Flemish Interuniversity Council (VLIR)
Nutrition Third World
Investigators
Principal Investigator: Lieven Huybregts, MSc University Ghent, Belgium
Study Chair: Patrick Kolsteren, PhD Institute of Tropical Medicine, Belgium; Ghent University, Belgium
Principal Investigator: Dominqiue Roberfroid, MD Institute of Tropical Medicine, Belgium
Principal Investigator: Nicolas Meda, PhD Centre Muraz
  More Information

Additional Information:
No publications provided by Institute of Tropical Medicine, Belgium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Patrick Kolsteren, head of Child Health and Nutrition Unit, Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT00909974     History of Changes
Other Study ID Numbers: ZEIN2004PR298
Study First Received: May 28, 2009
Last Updated: September 12, 2010
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Institute of Tropical Medicine, Belgium:
multiple micronutrients
energy deficiency

Additional relevant MeSH terms:
Birth Weight
Fetal Growth Retardation
Body Weight
Fetal Diseases
Growth Disorders
Pathologic Processes
Pregnancy Complications
Signs and Symptoms
Micronutrients
Trace Elements
Vitamin B 12
Vitamin B 6
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014