NCT00741143

Brief Summary

This study is designed to evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving cognition, hemoglobin, iron status and total body iron among school children in urban Bangalore.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
Last Updated

August 26, 2008

Status Verified

August 1, 2008

Enrollment Period

7 months

First QC Date

August 23, 2008

Last Update Submit

August 25, 2008

Conditions

Iron DeficiencyIron Deficiency AnemiaCognition

Keywords

Food FortificationIron deficiencyNaFeEdtaIron deficiency anemiaCognition

Outcome Measures

Primary Outcomes (1)

  • change in cognitive abilities

    7 months

Secondary Outcomes (1)

  • changes in iron status indicators

    7 months

Study Arms (2)

1

EXPERIMENTAL

Group that receives NaFeEDTA fortified wheat flour

Other: Fortification of wheat flour with NaFeEdta

2

PLACEBO COMPARATOR

Unfortified wheat flour

Other: Fortification of wheat flour with NaFeEdta

Interventions

Fortification of wheat flour with NaFeEdtaOTHER

NaFeEdta Fortified Wheat Flour (100g)provided as a lunch meal. Fortification level of 6mg Fe/100g/day/child for 7 months

12

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with depleted iron stores (serum ferritin \< 20 µg/L or iron deficiency serum transferrin receptor \>7.6 mg/L)

You may not qualify if:

  • Hb \< 8g/dl, any metabolic illness, use of medication, on iron supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Johns Research Institute

Bangalore, Karnataka, 560034, India

Location

Related Publications (1)

  • Muthayya S, Thankachan P, Hirve S, Amalrajan V, Thomas T, Lubree H, Agarwal D, Srinivasan K, Hurrell RF, Yajnik CS, Kurpad AV. Iron fortification of whole wheat flour reduces iron deficiency and iron deficiency anemia and increases body iron stores in Indian school-aged children. J Nutr. 2012 Nov;142(11):1997-2003. doi: 10.3945/jn.111.155135. Epub 2012 Sep 26.

    PMID: 23014487DERIVED

MeSH Terms

Conditions

Iron DeficienciesAnemia, Iron-Deficiency

Interventions

Fe(III)-EDTA

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sumithra Muthayya, PhD

    St Johns Research Institute, Sarjapur Road, Bangalore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2008

First Posted

August 26, 2008

Study Start

August 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 26, 2008

Record last verified: 2008-08

Locations

IN(1)