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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02804490
Date of registration:	15/06/2016
Prospective Registration:	No
Primary sponsor:	Johns Hopkins Bloomberg School of Public Health
Public title:	Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Scientific title:	Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Date of first enrolment:	March 2016
Target sample size:	255
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02804490
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
Phase:	Phase 3

Countries of recruitment
Zambia

Contacts

Name:	Rose Mwanza, MD
Address:
Telephone:
Email:
Affiliation:	Provincial Medical Office, Central Province, Zambia

Name:	Amanda C Palmer, PhD
Address:
Telephone:
Email:
Affiliation:	Johns Hopkins Bloomberg School of Public Health

Name:	Marjorie Haskell, PhD
Address:
Telephone:
Email:
Affiliation:	University of California, Davis

Key inclusion & exclusion criteria

Inclusion Criteria:

- Singleton birth

- No birth defects

- Free from chronic health conditions

- Infant received 100,000 IU vitamin A at 6 months of age

- Currently breastfeeding

- Not pregnant at 9 months post partum

- Hemoglobin > 8.0 g/dL for women and > 7.0 g/dL for infants

Exclusion Criteria:

- Multiple birth

- Birth defects

- Any chronic health condition requiring regular medical visits

- Infant did not receive vitamin A capsule at 6 months of age

- No longer breastfeeding

- Pregnant

- Hemoglobin = 8.0 g/dL for women or = 7.0 g/dL for infants

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Vitamin A Deficiency

Intervention(s)

Dietary Supplement: Provitamin A carotenoid biofortified maize

Dietary Supplement: Preformed vitamin A fortified maize

Dietary Supplement: Conventional white maize

Primary Outcome(s)

Infant vitamin A stores [Time Frame: 90 days]

Secondary Outcome(s)

Maternal dark adaptation [Time Frame: 90 days]

Maternal breast milk retinol [Time Frame: 90 days]

Maternal plasma retinol [Time Frame: 90 days]

Secondary ID(s)

2014H8314.JHU

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, Davis

Newcastle University

HarvestPlus

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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