Vitamin A Total Body Stores of Senegalese Children in Relation to Their Infectious Status

NCT03207308 | Completed

• 1 other identifier: RAF6047SEN
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Despite economic growth in developing countries, Sub-Saharan Africa still faces food insecurity malnutrition and infections. Micronutrient deficiency and infectious diseases still remain a public health problem and have a negative impact on health and the economy. They are both directly and indirectly responsible for children morbidity and mortality. Due to high level of children mortality (139‰) Vitamin A Supplementation (VAS) program was implemented in Senegal since 1999. A national representative study undertook in 2010 to have biological data on vitamin status and infections, showed that 24.4% of children aged 1-5 y were Vitamin A Deficiency (VAD) and 50.2% were infected. To address VAD issue, large scale oil fortification was launched by government and private industries also fortified bouillon cubes. Furthermore, home fortification is being initiated without evaluation of VAD control strategies existing in the country. In order to assess the impact of national VAD control strategies in Senegalese children, this study was designed to measure in subsample of rural children aged 3-5 y, the current vitamin A total body stores in relation to their infectious status.

Conditions

Infection; Vitamin A Overdose

Keywords

Vitamin A Status; Retinol Isotope dilution; Total body vitamin A stores; Children; Senegal

Outcome Measures

Primary Outcomes (1)

• Vitamin A status 1

  Total body pool size vitamin A (mmol)

  Within the coming 2 years

Secondary Outcomes (11)

• Acute infection

  Within the coming 2 years

• Chronic infection

  Within the coming 2 years

• Iron status

  Within the coming 2 years

• Stunting

  Within the coming 2 years

• Wasting

  Within the coming 2 years

Study Arms (1)

Vitamin A supplementation

EXPERIMENTAL

55 children will receive a Mega-dose of preformed Vitamin A as recommended by the Senegalese Ministry of Health

Dietary Supplement: Vitamin A supplementation

Interventions

Vitamin A supplementation DIETARY_SUPPLEMENT

200,000 IU of preformed vitamin A

Vitamin A supplementation

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years, not planning to move from the study area for the duration of the study, and do not have severe illness at the time of enrollment.

You may not qualify if:

• severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.

Sponsors & Collaborators

• Cheikh Anta Diop University, Senegal: lead
• International Atomic Energy Agency: collaborator

Study Sites (1)

Universite Cheikh Anta Diop

Dakar, Senegal

Location

MeSH Terms

Conditions

Infections

Study Officials

• Cornelia Loechl, PhD

  International Atomic Energy Agency

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: July 2, 2017
• Study Start: February 3, 2017
• Primary Completion: August 15, 2017
• Study Completion: December 1, 2017
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)