Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01061307
Other study ID # ETH2010/1
Secondary ID
Status Completed
Phase Phase 0
First received February 2, 2010
Last updated January 5, 2016
Start date September 2009
Est. completion date June 2010

Study information

Verified date April 2012
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel and sustainable approach to control these deficiencies.

Recently conducted extrusion trials have demonstrated that extruded rice grains containing iron, zinc and vitamin A show acceptable stability during production and storage and good sensory properties. The grains were produced using a twin-screw extruder equipped with a special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.

In this study the investigators plan to test the efficacy of the extruded triple fortified rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention trial in 7-12 y-old children. Children will be selected from primary schools in Satun Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As secondary outcome the effect on iron and vitamin A status will be investigated. The children will be randomized into two groups: a control group will receive a daily non-fortified rice lunch meal at school, while the second group will receive a daily rice meal containing the triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin, serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months, the baseline measurements will be repeated to judge the efficacy of the triple fortified rice.


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date June 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria:

- Preliminary screening: 650 children of 7-12 y-old children attending the primary school serving a low-income area in Muang district , Satun.(no exclusion criteria).

- Efficacy trial: 180-200 children, children with the Zn deficiency (serum zinc < 65, 66 and 70 µg/dL in children < 10y, male = 10y and female = 10y)

Exclusion Criteria:

- Children showing severe iron, zinc or vitamin A deficiency. These children will be excluded from the study and treated according to local policies.

- Significant chronic medical illness, including gastrointestinal, hematological, hepatic or renal disorders.

- Low school attendance (<80%).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Dietary Supplement:
fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice

Locations

Country Name City State
Switzerland Swiss Federal Institute of Technology Zurich Zurich
Thailand Institute of Nutrition Mahidol University Phuttamonthon Nakhon Pathom

Sponsors (2)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology Mahidol University

Countries where clinical trial is conducted

Switzerland,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum Zn September 2009-March 2010 No
Primary Hemoglobin September 2009-2010 No
Primary serum retinol September 2009-March 2010 No
Primary serum ferritin September 2009-March 2010 No
Primary ZPP September 2009- March 2010 No
Secondary Anthropometry measures September 2009-March 2010 No
See also
  Status Clinical Trial Phase
Completed NCT01483768 - Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients N/A
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Recruiting NCT02242188 - Supplementing Iron and Development in Breastfed Infants (SIDBI Study) Phase 4
Completed NCT02714361 - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women N/A
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT01991626 - Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT01687062 - Iron Absorption From Tef-injera in Women of Reproductive Age N/A
Completed NCT01573013 - Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children N/A
Completed NCT01443832 - Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study Phase 0
Completed NCT01191463 - The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals and Its Effect on Iron Status of Rural Indian Children (6-10 Years) N/A
Not yet recruiting NCT00515918 - The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants N/A
Recruiting NCT00378469 - Study of the Effects of Muscular Activity on Iron Metabolism N/A
Recruiting NCT05992116 - Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Completed NCT05262634 - Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester
Completed NCT06080555 - Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia Phase 1
Completed NCT04602247 - Evaluation of Iron Bioavailability From Iron Chlorophyllin N/A
Completed NCT02996786 - Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners N/A
Completed NCT02175888 - The Optimization of Bioavailability From Iron Supplements: Study 1 N/A
Completed NCT02280915 - Bioavailability of Iron From Savoury Food Product N/A