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

Micronutrient Deficiencies Clinical Trial

Official title:

The Effectiveness of Multiple Micronutrient Supplements Given by Teachers to School-Age Children on Growth and Educational Achievement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00859911
• Other study ID #: SCBD01
• Status: Active, not recruiting
• Phase: N/A
• First received: March 9, 2009
• Last updated: March 9, 2009
• Start date: March 2008
• Est. completion date: October 2011

Study information

• Verified date: March 2009
• Source: Save the Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Bangladesh Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2300
• Est. completion date: October 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Children enrolled in class 2

• Parents and child consented

Exclusion Criteria:

• Severely anaemic

• Physically disabled

Study Design

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

Related Conditions & MeSH terms

• Micronutrient Deficiencies

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Save the Children	Dhaka	Dhaka Division

Sponsors (3)

Lead Sponsor	Collaborator
Save the Children	Harvard University, University of Westminster

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tests of educational achievement and concentration		2 years	No
Primary	gains in weight and height		2 years	No
Secondary	haemoglobin concentration		2 years	No
Secondary	concentration of arsenic in hair		2 years	No