Condition category
Haematological Disorders
Date applied
04/05/2011
Date assigned
19/05/2011
Last edited
01/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Scott Rozelle

ORCID ID

Contact details

616 Serra Street
Encina Hall
East Wing
Room 402
Stanford
California
94305
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Nutrition and educational performance in rural China’s elementary schools: A multi-site cluster randomised controlled trial in Shaanxi province

Acronym

Study hypothesis

This study hypothesises that there is low haemoglobin count (which is known to be correlated with iron deficiency) among fourth-grade students in poor areas of Shaanxi province (Northwest China), and that the source of the problem is either nutritional deficiency, lack of information on nutritional practices, or intestinal worm infection.

Ethics approval

Stanford University Human Subjects Research Institutional Review Board approved on 27th January 2009 (IRB protocol number 15962)

Study design

Interventional multi-site cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Iron-deficiency anaemia

Intervention

Control Condition – 18 Schools
No intervention in these schools.

Deworming Intervention Only – 12 Schools
400 mg of albendazole given in a single, oral dose to all students in the school by home room teacher (unless students meet exclusion criteria)

Nutrition Supplement Intervention Only – 12 Schools
Multivitamin tablets containing 5 milligrams of iron given orally, daily for 5 months by home room teacher.

Each month we supplied teachers with 5 weeks worth of multivitamins with mineral supplements and disposable paper cups. During the first class period after the first meal of the day students always first go to their home room class. At least one period before the class, the teacher was supposed to boil a large kettle of water and let it cool. As soon as all of the students were in class, the teacher would hand out two disposable paper cups to each student. A multivitamin with mineral supplements was placed in one cup. The other cup was filled with water. The teacher would dispense the multivitamin with mineral supplements and water one student at a time and watch them take it. On each Friday afternoon, students would be given two multivitamins with mineral supplements to take home for the weekend. They were supposed to take one on Saturday and one on Sunday. Almost all parents that we talked to (during the spot checks) knew about the weekend protocol. Multivitamins with mineral supplements were dispensed from November to June. There was about a three week period during winter break when no multivitamins with mineral supplements were dispensed.

Deworming + Nutrition Supplement Treatment – 12 Schools
In 12 schools, students were given a 400 mg albendazole dose orally and also received the 5 mg iron dosage daily.

Information Treatment Only – 12 Schools
One of four letters (depending on students’ haemoglobin level) detailing the student’s specific anaemia status was sent home to parents or guardian two weeks after the baseline survey. The letter was sent home with the student and there was a follow up check by the home room teacher that parents received the letter. No other intervention or follow up was conducted.

The letter was written to describe to each parent what anaemia was and its known consequences. Parents were then told their own child’s haemoglobin (Hb) level. Their anaemia status was given as 1 of 4 categories: severely anaemic (Hb levels below 115 g/L); moderately anaemic (Hb levels between 115 and 120 g/L); not anaemic, but borderline (Hb levels between 120 and 130 g/L); or not anaemic (Hb levels 130 g/L or higher). Anaemic students were then told that they should consult a doctor and that anaemia is often associated with poor diet and that parents should strive to give their children a balanced diet that contains at least one ounce of meat per day.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Albendazole, iron tablets, multivitamins

Primary outcome measures

Haemoglobin concentrations, obtained by finger prick testing using HemoCue 201+ point of-care diagnostics, measured during the baseline (October 2008) and during the evaluation survey, nine months after the start of the treatments (June 2009)

Secondary outcome measures

The secondary outcome variable of our study came from a standardised math test that we administered ourselves at baseline (October 2008) and nine months after the start of the treatments (June 2009). The math test was based on questions drawn from a pool of questions that were originally created for The Trends in International Mathematics and Science Study (TIMSS). Enumerators required students to finish the 29 question test in 30 minutes. No extra time was given.

Overall trial start date

01/10/2008

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All fourth grade students (both male and female students ages 9 – 12 years) in 66 randomly selected rural primary schools in eight of the poorest counties in China's Shaanxi province, in China’s northwest region.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

In total, 3,821 students participated in this study

Participant exclusion criteria

1. Students found to be extremely anaemic (sent directly to a doctor for treatment) or low body weight
2. Students identified as having thalassaemia
3. Students not meeting inclusion criteria

Recruitment start date

01/10/2008

Recruitment end date

01/07/2009

Locations

Countries of recruitment

China

Trial participating centre

616 Serra Street, Encina Hall
California
94305
United States of America

Sponsor information

Organisation

Stanford University (USA)

Sponsor details

450 Serra Mall
Stanford
California
94305
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

LICOS Centre for Institutions and Economic Performance (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stanford University alumnus private donor (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23514770

Publication citations

  1. Results

    Zhang L, Kleiman-Weiner M, Luo R, Shi Y, Martorell R, Medina A, Rozelle S, Multiple micronutrient supplementation reduces anemia and anxiety in rural China's elementary school children., J. Nutr., 2013, 143, 5, 640-647, doi: 10.3945/jn.112.171959.

Additional files

Editorial Notes