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)

NCT01191463 | Completed

• 1 other identifier: MUGUST_2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency; Anemia

Outcome Measures

Primary Outcomes (1)

• Body Iron Stores

  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.

  Baseline (Start month=0), End of study (Month=7)

Secondary Outcomes (1)

• Prevalence of iron deficiency, Prevalence of Iron deficiency anemia

  Begin (Month=0), End (Month=7)

Study Arms (3)

Mung Bean Meals and Guava fruit

EXPERIMENTAL

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; Other: Guava

Mung Bean

ACTIVE COMPARATOR

Subjects in this group will receive a lunch meal based on 50g mung beans but without any vitamin C source.

Other: Mung Bean Meal

School feeding program

NO INTERVENTION

Subjects in this arm, will receive the regular school feeding program as provided by the school authorities

Interventions

Mung Bean Meal OTHER

50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.

Mung Bean; Mung Bean Meals and Guava fruit

Guava OTHER

A fresh Guava fruit will be provided raw (approx 100g fresh weight)

Mung Bean Meals and Guava fruit

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wageningen University: lead
• CCS Haryana Agricultural University Hisar, India: collaborator

Study Sites (1)

CCS Haryana Agricultural University

Hisar, Haryana State, India

Location

Related Publications (2)

• 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

  BACKGROUND

• Rani V, Moretti D, Khetarpaul N, Thankachan P, Zimmermann MB, Melse-Boonstra A, Brouwer ID. Vitamin C-Rich Guava Consumed with Mungbean Dal Reduces Anemia and Increases Hemoglobin but not Iron Stores: A Randomized Controlled Trial of Food-to-Food Fortification in Indian Children. J Nutr. 2024 Dec;154(12):3740-3748. doi: 10.1016/j.tjnut.2024.10.042. Epub 2024 Oct 30.

  PMID: 39481541 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Anemia

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Varsha Rani, PhD

  Wageningen University, Haryana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 29, 2011

Record last verified: 2010-09

Locations

IN (1)