Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Nutrition and educational performance in rural Chinas 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 students 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 childs 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 Chinas 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
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
-
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.