Trial record 6 of 27 for:    "Keratomalacia"

An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand

This study has been completed.
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
ETH Zurich, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01061307
First received: February 2, 2010
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Vitamin A Deficiency
Iron Deficiency
Zinc Deficiency
Dietary Supplement: fortified extruded rice
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • serum Zn [ Time Frame: September 2009-March 2010 ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: September 2009-2010 ] [ Designated as safety issue: No ]
  • serum retinol [ Time Frame: September 2009-March 2010 ] [ Designated as safety issue: No ]
  • serum ferritin [ Time Frame: September 2009-March 2010 ] [ Designated as safety issue: No ]
  • ZPP [ Time Frame: September 2009- March 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometry measures [ Time Frame: September 2009-March 2010 ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
Dietary Supplement: fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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%).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061307

Locations
Switzerland
Swiss Federal Institute of Technology Zurich
Zurich, Switzerland, 8092
Thailand
Institute of Nutrition Mahidol University
Phuttamonthon, Nakhon Pathom, Thailand, 73170
Sponsors and Collaborators
Swiss Federal Institute of Technology
Mahidol University
  More Information

No publications provided by Swiss Federal Institute of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ETH Zurich, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01061307     History of Changes
Other Study ID Numbers: ETH2010/1
Study First Received: February 2, 2010
Last Updated: April 4, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Swiss Federal Institute of Technology:
Fe deficiency, Zn deficiency, vitamin A deficiency

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014