- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00859911
The Effectiveness of Micronutrient Supplements on Growth and Educational Achievement of Schoolchildren in Bangladesh
March 9, 2009 updated by: Save the Children
The Effectiveness of Multiple Micronutrient Supplements Given by Teachers to School-Age Children on Growth and Educational Achievement
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dhaka Division
-
Dhaka, Dhaka Division, Bangladesh
- Save the Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children enrolled in class 2
- Parents and child consented
Exclusion Criteria:
- Severely anaemic
- Physically disabled
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 2
Thiamine Mononitrate 5mg, Riboflavin 2 mg, Niacin amide 20 mg, Pyridoxine hydrochloride 2 mg
|
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 Names:
|
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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tests of educational achievement and concentration
Time Frame: 2 years
|
2 years
|
gains in weight and height
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
haemoglobin concentration
Time Frame: 2 years
|
2 years
|
concentration of arsenic in hair
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Hall, PhD, University of Westminster
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ANTICIPATED)
March 1, 2011
Study Completion (ANTICIPATED)
October 1, 2011
Study Registration Dates
First Submitted
March 9, 2009
First Submitted That Met QC Criteria
March 9, 2009
First Posted (ESTIMATE)
March 11, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
March 11, 2009
Last Update Submitted That Met QC Criteria
March 9, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCBD01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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