NCT03835377

Brief Summary

The objective of this cluster-randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to control beans (Control-Beans). A cluster-randomized trial of biofortified beans (Phaseolus vulgaris L), bred to enhance iron content, was conducted for 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
574

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2010

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

January 11, 2019

Last Update Submit

February 18, 2019

Conditions

Iron-deficiencyAnemia

Keywords

IronBiofortificationIron deficiencyAnemiaChildrenMexico

Outcome Measures

Primary Outcomes (5)

  • Change in hemoglobin

    Hemoglobin (Hb)

    6 months

  • Change in serum ferritin

    Serum ferritin (SF)

    6 months

  • Change in sTfR

    Soluble transferrin receptor (sTfR)

    6 months

  • Anemia

    Hb \<115 g/L for \<12 y; \<120 g/L for \>=12 y

    6 months

  • Iron deficiency (SF)

    Serum ferritin \<15.0 µg/L

    6 months

Secondary Outcomes (3)

  • Change in TBI

    6 months

  • Iron deficiency (TBI)

    6 months

  • Iron deficiency (sTfr)

    6 months

Study Arms (2)

Iron-biofortified beans

EXPERIMENTAL

Iron-biofortified beans (Phaseolus vulgaris L MIB465)

Other: Iron-biofortified beans

Control beans

ACTIVE COMPARATOR

Control beans (Phaseolus vulgaris L Jamapa variety)

Other: Control beans

Interventions

Iron-biofortified beansOTHER

Iron-biofortified beans (Phaseolus vulgaris L MIB465)

Also known as: Fe-Beans
Iron-biofortified beans
Control beansOTHER

Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size

Also known as: Control-Beans
Control beans

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Boarding schools for children (5-12 y)
  • Located in a rural area approximately 60 kilometers east of the city of Oaxaca
  • A high prevalence of anemia (\>=15.0%) on the baseline survey

You may not qualify if:

  • A prevalence of anemia \<15.0% on the baseline survey
  • Inadequate infrastructure to sustain a 6-month feeding trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Salud Publica (INSP)

Cuernavaca, Morelos, Mexico

Location

Related Publications (1)

  • Finkelstein JL, Mehta S, Villalpando S, Mundo-Rosas V, Luna SV, Rahn M, Shamah-Levy T, Beebe SE, Haas JD. A Randomized Feeding Trial of Iron-Biofortified Beans on School Children in Mexico. Nutrients. 2019 Feb 12;11(2):381. doi: 10.3390/nu11020381.

    PMID: 30759887DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemiaIron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Salvador Villalpando, MD PhD

    Instituto Nacional de Salud Publica (INSP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study was a double-blind, cluster-randomized controlled trial (with randomization at the school level) of: (1) iron-biofortified black beans, compared to (2) a commercial variety of beans, with the intervention randomized at the school level. School administrators, children, research staff (i.e. managing the intervention, food weighing, assessment of outcomes), and laboratory staff were blinded to the intervention group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

February 8, 2019

Study Start

January 6, 2010

Primary Completion

June 25, 2010

Study Completion

August 15, 2010

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)