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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) (MUGUST_2)

This study has been completed.
Sponsor:
Collaborator:
CCS Haryana Agricultural University Hisar, India
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01191463
First received: August 27, 2010
Last updated: September 28, 2011
Last verified: September 2010
  Purpose

Iron deficiency is estimated to affect about one fifth of the world's population, and women and children are among the most severely affected. Evidence is mounting that iron deficiency anemia adversely affects brain development with measurable effects on children's behavior, motor development and cognition. In Hisar district of Haryana state, north- India, 58% of school age children (6-10 years) are anemic, 49 % are iron deficient whereas 40 % have been found to be anemic due to iron deficiency. Iron bioavailability calculated using algorithms in regional diets ranged from 3.2 to 4.6 percent. Mungbean (Vigna radiata L.) is the third most important legume crop of India. It is a high potential legume crop with 4-8 mg of iron and known as a nutritious and healthy legume. Ascorbic acid is a potent enhancer of iron absorption in humans which can counteract the inhibitory effect of phytic acid and polyphenols. Guava is a popular and easily available fruit for this community having 200- 300 mg/100g of ascorbic acid. We will conduct a randomised controlled trial in school age children (6-10 years) in Haryana state of India, to determine the efficacy of local vitamin-C rich fruit guava with mungbean based meal on iron status of rural Indian children.

Objective: To assess the effect of mungbean based test meal on iron status (as body iron stores, defined and calculated by the ratio of serum ferritin and serum transferrin receptor) of school age children (6-10 years) with and without the consumption of guava, a vitamin C rich fruit, in a school feeding program for seven months.

Study population: Three hundred school children aged between 6-10 years will be recruited from two government school of Mangali village situated in Hisar district of Haryana state.

Study design: This intervention study will be carried out in a randomized controlled design. Main study parameters/endpoints: Primary outcome will be the measurement of body iron stores (mg/kg of body weight) based on the ratio of serum transferrin receptor to serum ferritin.


Condition Intervention
Iron Deficiency
Anemia
Other: Mung Bean Meal
Other: Guava

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals in Indian Children (6-10 Years)

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Body Iron Stores [ Time Frame: Baseline (Start month=0), End of study (Month=7) ] [ Designated as safety issue: No ]
    Defined as the ration between serum ferritin and soluble serum transferrin recpetor Body iron stores are a sensitive measure of body iron balance and indicative of body iron changes.


Secondary Outcome Measures:
  • Prevalence of iron deficiency, Prevalence of Iron deficiency anemia [ Time Frame: Begin (Month=0), End (Month=7) ] [ Designated as safety issue: No ]
    Anemia will be defined as a hemoglobin concentration <11.5g/L and iron deficiency will be defined as an SF concentration <12µg/l.


Estimated Enrollment: 300
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mung Bean Meals and Guava fruit
Subject in this group will receive, a lunch meal based on 50g of Mung beans together with a local, Vitamin C rich fruit (Guava)
Other: Mung Bean Meal
50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.
Other: Guava
A fresh Guava fruit will be provided raw (approx 100g fresh weight)
Active Comparator: Mung Bean
Subjects in this group will receive a lunch meal based on 50g mung beans but without any vitamin C source.
Other: Mung Bean Meal
50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.
No Intervention: School feeding program
Subjects in this arm, will receive the regular school feeding program as provided by the school authorities

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • School children (6-10) years of age
  • Enrolled in selected primary schools
  • Informed consent obtained from at least one parent or guardian
  • Children should be apparently healthy; i.e. have no pre-existing medical conditions or be receiving chronic medication.
  • Should not be allergic / hypersensitive to any of the ingredients of the test meal
  • Should not consume mineral/vitamin supplements. If the child consume supplements he/she will be asked to stop taking the supplements two weeks before the study and during the study

Exclusion Criteria:

  • Subjects with severe anemia (Hb=70 g/L)will be referred for treatement at the local health facility.
  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: NCT01191463

Locations
India
CCS Haryana Agricultural University
Hisar, Haryana State, India
Sponsors and Collaborators
Wageningen University
CCS Haryana Agricultural University Hisar, India
Investigators
Principal Investigator: Varsha Rani, PhD Wageningen University, Haryana University
  More Information

Additional Information:
Publications:
Rani, V., Brouwer, Inge., Khetarpaul, N., Zimmerman, M.B. (2009) Iron status and associated factors in rural school going children (5-8 years) of Haryana state, India., Abstract Book Wageningen Nutritional Sciences Forum March 4-6, 2009 European Journal of Clinical Nutrition, 63 (3S) Pp:20

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01191463     History of Changes
Other Study ID Numbers: MUGUST_2
Study First Received: August 27, 2010
Last Updated: September 28, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ascorbic Acid
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 25, 2014