The Effectiveness of Micronutrient Supplements on Growth and Educational Achievement of Schoolchildren in Bangladesh

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Save the Children.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Westminster
Harvard University
Information provided by:
Save the Children
ClinicalTrials.gov Identifier:
NCT00859911
First received: March 9, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

This is a study of the effectiveness of multiple micronutrient supplements given by teachers to their pupils on growth and educational achievements. The hypothesis is that children are deficient in multiple micronutrients and that supplements will lead to improved weight gain, growth in height and better educational achievements in tests of mathematics and language. It is also hypothesised that micronutrients will help prevent the build up of arsenic consumed in food and water as a result of geological contamination of water sources.


Condition Intervention
Micronutrient Deficiencies
Dietary Supplement: Multiple micronutrients

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness of Multiple Micronutrient Supplements Given by Teachers to School-Age Children on Growth and Educational Achievement

Resource links provided by NLM:


Further study details as provided by Save the Children:

Primary Outcome Measures:
  • tests of educational achievement and concentration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • gains in weight and height [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • haemoglobin concentration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • concentration of arsenic in hair [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 2300
Study Start Date: March 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Thiamine Mononitrate 5mg, Riboflavin 2 mg, Niacin amide 20 mg, Pyridoxine hydrochloride 2 mg
Dietary Supplement: Multiple micronutrients
A tablet on three days a week containing: Vitamin A 1500 µg, Vitamin D 15 µg, Thiamine Mononitrate 1.22 mg, Riboflavin 1.7 mg, Ascorbic Acid 60 mg, Niacin amide 20 mg, Pyridoxine hydrochloride 2 mg, Folic Acid 400 µg, Calcium pantothenate 10.8 mg, Cyanocoblamin 6 µg, Vitamin E 18 IU, ferrous sulphate 19 mg, potassium iodide 145 µg, Potassium sulphate 11 mg, Manganese sulphate 0.38 mg, copper sulphate 0.509 mg, zinc sulphate 15 mg
Other Name: V-Plex Plus, Acme Pharmaceuticals Bangladesh
Experimental: 1
Vitamin A 1500 µg, Vitamin D 15 µg, Thiamine Mononitrate 1.22 mg, Riboflavin 1.7 mg, Ascorbic Acid 60 mg, Niacin amide 20 mg, Pyridoxine hydrochloride 2 mg, Folic Acid 400 µg, Calcium pantothenate 10.8 mg, Cyanocobalamin 6 µg, Vitamin E 18 IU, ferrous sulphate 19 mg, potassium iodide 145 µg, Potassium sulphate 11 mg, Manganese sulphate 0.38 mg, copper sulphate 0.509 mg, zinc sulphate 15 mg
Dietary Supplement: Multiple micronutrients
A tablet on three days a week containing: Vitamin A 1500 µg, Vitamin D 15 µg, Thiamine Mononitrate 1.22 mg, Riboflavin 1.7 mg, Ascorbic Acid 60 mg, Niacin amide 20 mg, Pyridoxine hydrochloride 2 mg, Folic Acid 400 µg, Calcium pantothenate 10.8 mg, Cyanocoblamin 6 µg, Vitamin E 18 IU, ferrous sulphate 19 mg, potassium iodide 145 µg, Potassium sulphate 11 mg, Manganese sulphate 0.38 mg, copper sulphate 0.509 mg, zinc sulphate 15 mg
Other Name: V-Plex Plus, Acme Pharmaceuticals Bangladesh

Detailed Description:

This study is a randomised double blind controlled cluster trial of the effectiveness of multiple micronutrient supplements given by teachers to schoolchildren on improving their growth, nutritional status and educational achievement. The primary outcome measures are: gains in weight and height, haemoglobin concentration, cognitive function and educational achievement. Secondary outcomes are other anthropometric measurements and a decrease in body arsenic deposits. One hundred schools in Meherpur District, Bangladesh will take part in this study. Participation will be on the basis of informed consent. All pupils will be dewormed twice a year using a single dose of 400 mg albendazole; this will promote the bioavailability of the micronutrient supplements. The schools will be randomly allocated into two groups. In one group of 50 schools all children will be given by their teachers a single tablet of multiple micronutrients on every other school day each week, so for a total of 3 days a week or about 125 school days a year, depending on school and national holidays. This supplement will make a substantial contribution over a period of one year to each child's recommended intake of iron, iodine, zinc, vitamin A, vitamin B12, folate and four B-group vitamins. Some of these micronutrients, such as vitamin A and iron, can be stored in the body, in addition to meeting current nutritional requirements. Children in the other 50 schools will receive a tablet identical in weight, shape, size and appearance that contains the same four B-group vitamins as the multiple micronutrient supplement. The B-group vitamins are not expected to have a major effect on any of the outcome measures, but may provide some benefit to children in the comparison group. Both supplements are formulated according to UK and US pharmacopoeias by Acme Pharmaceuticals and are being purchased by Save the Children. Both supplements will be given free on three days a week to an estimated 30,000 pupils in all 100 study schools for a period of two school years. The subjects for study will be up to 30 randomly selected children in class 2 in the age range 7 - 8 years in all 100 schools. An equal number of boys and girls will be selected. The actual number will depend on enrolment in class 2 in each school. A baseline survey will be done before the supplements are started to measure the following: weight, height and other anthropometric measurements to assess growth; the prevalence of intestinal worm infections in a 20% sub-sample; the haemoglobin concentration in a drop of blood taken from a finger prick from a sub-sample of about 66% of all children; the concentration of arsenic in hair in a sub-sample of about 20% of all children; tests of cognitive function including concentration in all children; and tests of educational achievement in mathematics and language in all children. These measurements, analyses and assessments will be repeated two years later when the cohort of up to 1,500 children in each study group are in class 4. The magnitude and statistical significance of differences in the mean differences in outcome values between study groups will indicate the impact of the multiple micronutrient supplement in comparison with B-group vitamins alone.

  Eligibility

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

Inclusion Criteria:

  • Children enrolled in class 2
  • Parents and child consented

Exclusion Criteria:

  • Severely anaemic
  • Physically disabled
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859911

Locations
Bangladesh
Save the Children
Dhaka, Dhaka Division, Bangladesh
Sponsors and Collaborators
Save the Children
University of Westminster
Harvard University
Investigators
Principal Investigator: Andrew Hall, PhD University of Westminster
  More Information

No publications provided

Responsible Party: Andrew Hall, University of Westminster
ClinicalTrials.gov Identifier: NCT00859911     History of Changes
Other Study ID Numbers: SCBD01
Study First Received: March 9, 2009
Last Updated: March 9, 2009
Health Authority: Bangladesh: Bangladesh Medical Research Council

Keywords provided by Save the Children:
micronutrients

Additional relevant MeSH terms:
Pantothenic Acid
Pyridoxine
Vitamin B 6
Thiamine
Micronutrients
Trace Elements
Vitamin B Complex
Vitamins
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014