Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children

NCT01814891 | Completed

• 1 other identifier: Zambia II
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize.

Conditions

Vitamin A Status With Maize Feeding

Keywords

vitamin A; maize; total body reserves; Condition is vitamin A status.; Focus: change in vitamin A status with maize feeding.; Focus: feeding orange maize to children for 90 days.; Focus: total body reserves of vitamin A.

Outcome Measures

Primary Outcomes (1)

• Vitamin A status changes

  Vitamin A status is measured before and after the intervention.

  After the intervention, which is approximately 3 months.

Study Arms (3)

Orange maize

EXPERIMENTAL

Children were fed orange maize and the intervention name was "orange"

Other: Orange maize feeding

Blue vitamin A group

ACTIVE COMPARATOR

Received vitamin A in the form of retinyl palmitate in oil at the estimated average requirment.

Other: Vitamin A supplement

White

PLACEBO COMPARATOR

Received oil only at the same volume as the vitamin A group

Other: Oil only

Interventions

Orange maize feeding OTHER

This group was fed orange maize.

Orange maize

Vitamin A supplement OTHER

This group received a dose of vitamin A at the estimated average requirement each feeding day of the intervention.

Blue vitamin A group

Oil only OTHER

This group received a small amount of plain oil without vitamin A.

White

Eligibility Criteria

• Age: 57 Months - 88 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 57-88 months at the time of initiation of the study
• Children living in the locality defined by the study and not enrolled in school.
• Consent from parent/guardian.

You may not qualify if:

• Severely malnourished children (weight for age or height z-scores \<-3 standard deviations below the WHO growth reference standards)
• Children found to be below 57 months and still holding an under five card or above 88 months at the time of initiation of the study or enrolled in school, based on verification of birth dates at screening
• Children whose families plan to leave the study area before completion of the study
• Consent not obtained from parent/guardian
• Children suffering from diarrhea at the time of initiation of the study or with high fever, based on the report of symptoms by the parent/guardian
• Children with severe anemia (Hb \<7.0 g/dL) as determined at the baseline blood draw.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Related Publications (6)

• Sheftel J, Valentine AR, Hull AK, Fadjarwati T, Gannon BM, Davis CR, Tanumihardjo SA. Findings in 3 clinical trials challenge the accuracy of the Institute of Medicine's estimated average requirements for vitamin A in children and women. Am J Clin Nutr. 2021 May 8;113(5):1322-1331. doi: 10.1093/ajcn/nqaa132.

  PMID: 32492125 DERIVED

• Tanumihardjo SA, Gannon BM, Kaliwile C, Chileshe J, Binkley NC. Restricting vitamin A intake increases bone formation in Zambian children with high liver stores of vitamin. Arch Osteoporos. 2019 Jun 28;14(1):72. doi: 10.1007/s11657-019-0617-y.

  PMID: 31254130 DERIVED

• Titcomb TJ, Schmaelzle ST, Nuss ET, Gregory JF 3rd, Tanumihardjo SA. Suboptimal Vitamin B Intakes of Zambian Preschool Children: Evaluation of 24-Hour Dietary Recalls. Food Nutr Bull. 2018 Jun;39(2):281-289. doi: 10.1177/0379572118760373. Epub 2018 Mar 11.

  PMID: 29528727 DERIVED

• Suri DJ, Tanumihardjo JP, Gannon BM, Pinkaew S, Kaliwile C, Chileshe J, Tanumihardjo SA. Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children. Am J Clin Nutr. 2015 Nov;102(5):1259-65. doi: 10.3945/ajcn.115.113050. Epub 2015 Oct 7.

  PMID: 26447158 DERIVED

• Mondloch S, Gannon BM, Davis CR, Chileshe J, Kaliwile C, Masi C, Rios-Avila L, Gregory JF 3rd, Tanumihardjo SA. High provitamin A carotenoid serum concentrations, elevated retinyl esters, and saturated retinol-binding protein in Zambian preschool children are consistent with the presence of high liver vitamin A stores. Am J Clin Nutr. 2015 Aug;102(2):497-504. doi: 10.3945/ajcn.115.112383. Epub 2015 Jul 15.

  PMID: 26178727 DERIVED

• Gannon B, Kaliwile C, Arscott SA, Schmaelzle S, Chileshe J, Kalungwana N, Mosonda M, Pixley K, Masi C, Tanumihardjo SA. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial. Am J Clin Nutr. 2014 Dec;100(6):1541-50. doi: 10.3945/ajcn.114.087379. Epub 2014 Oct 8.

  PMID: 25411289 DERIVED

MeSH Terms

Conditions

Callosities

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 20, 2013
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 20, 2013

Record last verified: 2013-03