NCT01614483

Brief Summary

The overall aim of the project is to provide proof-of-principle that biofortification of cassava with vitamin A is a viable strategy to improve vitamin A status of deficient populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
341

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

June 1, 2012

Last Update Submit

November 16, 2022

Conditions

Vitamin A Deficiency

Keywords

Vitamin A deficiencyBiofortificationCassavaB-caroteneSchool childrenKenya

Outcome Measures

Primary Outcomes (1)

  • Change in serum retinol concentration

    Baseline, end of study (4 months)

Secondary Outcomes (6)

  • Immune function indicators

    End of study (4 months)

  • Bioefficacy

    Baseline, end of study (4 months)

  • Functional indicators

    End of study (4 months)

  • Thyroid function

    End of study (4 months

  • Effect modification

    Baseline

  • +1 more secondary outcomes

Study Arms (3)

Yellow cassava + placebo capsule

EXPERIMENTAL
Other: Yellow cassava

White cassava + placebo capsule

PLACEBO COMPARATOR
Other: White cassava

White cassava + B-carotene capsule

ACTIVE COMPARATOR
Other: White cassava

Interventions

Yellow cassavaOTHER

Daily provision of 375 g boiled yellow cassava for 18 weeks, 6 days/week Daily provision of placebo capsule for 18 weeks, 6 days/week

Yellow cassava + placebo capsule
White cassavaOTHER

Daily provision of 375 g boiled white cassava for 18 weeks, 6 days/ week Daily provision of placebo capsule for 18 weeks, 6 days/ week

White cassava + placebo capsule

Eligibility Criteria

Age61 Months - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Low vitamin A status (retinol binding protein (RBP) at the lowest end of the distribution will be included in the study)

You may not qualify if:

  • History or signs of infectious or systemic diseases (e.g. tuberculosis, sickle cell anaemia)
  • Anaemia, malaria or acute inflammation at the day of baseline measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kibwezi District

Kibwezi, Eastern Kenya, Kenya

Location

Related Publications (3)

  • Talsma EF, Brouwer ID, Verhoef H, Mbera GN, Mwangi AM, Demir AY, Maziya-Dixon B, Boy E, Zimmermann MB, Melse-Boonstra A. Biofortified yellow cassava and vitamin A status of Kenyan children: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):258-67. doi: 10.3945/ajcn.114.100164. Epub 2015 Dec 16.

    PMID: 26675768BACKGROUND

  • Talsma EF, Melse-Boonstra A, de Kok BP, Mbera GN, Mwangi AM, Brouwer ID. Biofortified cassava with pro-vitamin A is sensory and culturally acceptable for consumption by primary school children in Kenya. PLoS One. 2013 Aug 30;8(8):e73433. doi: 10.1371/journal.pone.0073433. eCollection 2013.

    PMID: 24023681BACKGROUND

  • Talsma EF, Borgonjen-van den Berg KJ, Melse-Boonstra A, Mayer EV, Verhoef H, Demir AY, Ferguson EL, Kok FJ, Brouwer ID. The potential contribution of yellow cassava to dietary nutrient adequacy of primary-school children in Eastern Kenya; the use of linear programming. Public Health Nutr. 2018 Feb;21(2):365-376. doi: 10.1017/S1368980017002506. Epub 2017 Oct 2.

    PMID: 28965533BACKGROUND

Related Links

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Alida Melse, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 8, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 21, 2022

Record last verified: 2022-11

Locations

KE(1)