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

NCT00859911 | Unknown

• 1 other identifier: SCBD01
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Micronutrient Deficiencies

Keywords

micronutrients

Outcome Measures

Primary Outcomes (2)

• tests of educational achievement and concentration

  2 years

• gains in weight and height

  2 years

Secondary Outcomes (2)

• haemoglobin concentration

  2 years

• concentration of arsenic in hair

  2 years

Study Arms (2)

2

ACTIVE COMPARATOR

Thiamine Mononitrate 5mg, Riboflavin 2 mg, Niacin amide 20 mg, Pyridoxine hydrochloride 2 mg

Dietary Supplement: Multiple micronutrients

1

EXPERIMENTAL

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

Interventions

Multiple micronutrients DIETARY_SUPPLEMENT

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

Also known as: V-Plex Plus, Acme Pharmaceuticals Bangladesh

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children enrolled in class 2
• Parents and child consented

You may not qualify if:

• Severely anaemic
• Physically disabled

Sponsors & Collaborators

• Save the Children: lead
• University of Westminster: collaborator
• Harvard University: collaborator

Study Sites (1)

Save the Children

Dhaka, Dhaka Division, Bangladesh

Location

Study Officials

• Andrew Hall, PhD

  University of Westminster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 11, 2009

Record last verified: 2009-03

Locations

BA (1)