Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children

Vitamin A Deficiency Clinical Trial

Official title:

Efficacy of β-carotene Biofortified Maize in Improving Vitamin A Status and Reducing the Prevalence of Vitamin A Deficiency Among Children in Rural Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695148
• Other study ID #: JHU IRB 4150
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2012
• Last updated: February 5, 2014
• Start date: August 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Tropical Diseases Research Centre, Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.

Description:

Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40% of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi region of rural Zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. An additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1228
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• Children 4-8 years of age

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Low Serum Retinol
• Night Blindness
• Vitamin A Deficiency

Intervention

Dietary Supplement:
• ß-Carotene Biofortified Maize Flour

• White Maize Flour

Locations

Country	Name	City	State
Zambia	JHU Office	Mkushi

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Canadian International Development Agency, HarvestPlus, National Food and Nutrition Commission, Zambia, Tropical Diseases Research Centre, Zambia, Zambia Agriculture Research Institute

Country where clinical trial is conducted

Zambia, 

References & Publications (5)

Davis C, Jing H, Howe JA, Rocheford T, Tanumihardjo SA. beta-Cryptoxanthin from supplements or carotenoid-enhanced maize maintains liver vitamin A in Mongolian gerbils ( Meriones unguiculatus) better than or equal to beta-carotene supplements. Br J Nutr. 2008 Oct;100(4):786-93. doi: 10.1017/S0007114508944123. Epub 2008 Mar 3. — View Citation

Davis CR, Howe JA, Rocheford TR, Tanumihardjo SA. The xanthophyll composition of biofortified maize (Zea mays Sp.) does not influence the bioefficacy of provitamin a carotenoids in Mongolian gerbils (Meriones unguiculatus). J Agric Food Chem. 2008 Aug 13;56(15):6745-50. doi: 10.1021/jf800816q. Epub 2008 Jul 11. — View Citation

Howe JA, Tanumihardjo SA. Carotenoid-biofortified maize maintains adequate vitamin a status in Mongolian gerbils. J Nutr. 2006 Oct;136(10):2562-7. — View Citation

Howe JA, Tanumihardjo SA. Evaluation of analytical methods for carotenoid extraction from biofortified maize (Zea mays sp.). J Agric Food Chem. 2006 Oct 18;54(21):7992-7. — View Citation

Muzhingi T, Gadaga TH, Siwela AH, Grusak MA, Russell RM, Tang G. Yellow maize with high ß-carotene is an effective source of vitamin A in healthy Zimbabwean men. Am J Clin Nutr. 2011 Aug;94(2):510-9. doi: 10.3945/ajcn.110.006486. Epub 2011 Jun 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased Serum Retinol Concentration	The investigators hypothesize a difference of 2.5 µg/dL or more in serum retinol among children receiving biofortified versus white maize flour-based meals. Serum retinol measures will be collected at baseline and at the end of 6 months and assessed by a High Performance Liquid Chromatography assay.	After 6 months of feeding	No
Primary	Decreased Prevalence of Vitamin A deficiency	The investigators hypothesize a difference of 10% or more in the prevalence of vitamin A deficiency (i.e., serum retinol < 0.7 µmol/l) among children consuming biofortified versus white maize flour-based meals, assuming a baseline prevalence of 40%.	After 6 months of feeding	No
Secondary	Improved Dark Adaptation	The investigators hypothesize a difference in pupillary response to a light stimulus, as detected by dark adaptometry, in children receiving biofortified versus white maize flour-based meals.	After 6 months of Feeding	No