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Micronutrient DeficienciesNCT00859911

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

A study testing Multiple micronutrients in people with Micronutrient Deficiencies, run by Save the Children at 1 site in Bangladesh.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Micronutrient Deficiencies
What is being tested?
Multiple micronutrients
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,300 participants
Where
1 siteBangladesh
Study dates
Mar 2008to Oct 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Children enrolled in class 2
  • Parents and child consented

Who cannot join

  • Severely anaemic
  • Physically disabled

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • Save the Children

    Dhaka, Dhaka Division

Other trials in Bangladesh

About this study

Official title: 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.

Read the 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.

Being tested
Multiple micronutrients
Keywords
micronutrients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiple micronutrientsDietary supplement

    Also called V-Plex Plus, Acme Pharmaceuticals Bangladesh

    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

Study groups in NCT00859911
Study groupRoleWhat they receive
2Active comparatorThiamine Mononitrate 5mg, Riboflavin 2 mg, Niacin amide 20 mg, Pyridoxine hydrochloride 2 mg
Receives: Dietary Supplement: Multiple micronutrients
1ExperimentalVitamin 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
Receives: Dietary Supplement: Multiple micronutrients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tests of educational achievement and concentration

    Measured: 2 years

  2. gains in weight and height

    Measured: 2 years

Secondary outcomes (2)
  1. haemoglobin concentration

    Measured: 2 years

  2. concentration of arsenic in hair

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2009 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2011 (estimated)
  4. Study completionOct 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00859911
Sponsor's protocol ID
SCBD01
Status last verified
Mar 2009
First submitted
9 Mar 2009
Last updated
11 Mar 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Multiple micronutrients in people with Micronutrient Deficiencies, run by Save the Children at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tests of educational achievement and concentration (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2009.

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