Vitamin A Deficiency Clinical Trial
— CASSAVITAOfficial title:
Efficacy of Yellow Cassava to Improve Vitamin A Status of Mildly Deficient Primary School Children in Kenya: a Randomized Controlled Trial
NCT number | NCT01614483 |
Other study ID # | INSTAPAWP2YC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2012 |
Est. completion date | November 2012 |
Verified date | November 2022 |
Source | Wageningen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 341 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 61 Months to 13 Years |
Eligibility | Inclusion Criteria: - Low vitamin A status (retinol binding protein (RBP) at the lowest end of the distribution will be included in the study) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Kibwezi District | Kibwezi | Eastern Kenya |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | European Commission, University of Nairobi |
Kenya,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum retinol concentration | Baseline, end of study (4 months) | ||
Secondary | Immune function indicators | neopterin, IL-2, IL4, IL10, IL13, TNF-a, IFN-?, TGF-ß in serum; IgA in saliva | End of study (4 months) | |
Secondary | Bioefficacy | Comparison of change in serum retinol between yellow cassava group and positive control (B-carotene supplement group) | Baseline, end of study (4 months) | |
Secondary | Functional indicators | Gut integrity, dark adaptation, morbidity | End of study (4 months) | |
Secondary | Thyroid function | Serum Tg, TSH | End of study (4 months | |
Secondary | Effect modification | Serum zinc, serum retinol, iron status, polymorphisms | Baseline | |
Secondary | Anemia | Hemoglobin | End of study (4 months) |
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