Effect of African Leafy Vegetables on Nutritional Status of South African School Children.

Malnutrition Clinical Trial

— ALV  

Official title:

The Effect of African Leafy Vegetables on Nutritional Status (Including Iron, Zinc and Vitamin A Status) of School Children Residing in Semi-rural Farm Community in the North West Province of South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920646
• Other study ID #: ALV study
• Status: Completed
• Phase: N/A
• First received: August 8, 2013
• Last updated: August 9, 2013
• Start date: February 2012
• Est. completion date: June 2012

Study information

• Verified date: August 2013
• Source: North-West University, South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics CommitteeSouth Africa: Department of Health
• Study type: Interventional

Clinical Trial Summary

The combination of poverty-related infectious and lifestyle-related non-communicable diseases, both driven by malnutrition, causes a high burden for South Africa. Healthy and nutritious diets for populations depend on availability and accessibility of a variety of plant and animal foods, within a context that promotes and supports healthy behaviour. Food based strategies, such as supplementation, food fortification, and diversification of crops, are used to achieve optimal dietary requirements to combat malnutrition, including micronutrient deficiencies. A more sustainable food based strategy is the (promotion of) use of indigenous and traditional foods, such as African Leafy Vegetables (ALVs). Unfortunately, several studies from all over Africa have shown that there is a shift from traditional diets as result of the preparing techniques and the absence of women in homes. Furthermore, indigenous and traditional foods are considered as "poor people's food".

Against this background, a joint project between South Africa, Kenya and Benin is designed to fill the gaps in knowledge in these countries regarding the availability, acceptability and consumption and evidenced based benefits of foods from local biodiversity. The main aim of the study in South Africa is to provide empirical evidence of how the role of biodiversity can be translated into improved health status in contemporary poor rural and urban communities in the North West Province of South Africa. In order to achieve this it is important to gain knowledge on the possibility of using ALVs as a strategy to alleviate micronutrient deficiencies. Therefore an intervention study to determine the effect of selected ALV on the nutritional status (including zinc, iron, and vitamin A status) of school children (grade R-4) residing in contemporary poor rural community in the North West Province, South Africa has been designed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• apparently healthy and had no signs and symptoms of acute illness at the time of baseline blood collection

• attending grade R - 4 of one of the selected schools

Exclusion Criteria:

• Children with a haemoglobin concentration <8 g/dL were excluded from the study and referred for medical treatment.

• Children who received micronutrient supplements were also excluded from the study.

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Iron Status
• Malnutrition
• Vitamin A Status
• Zinc Status

Intervention

Other:
• ALV
Random allocation of children of two rural farm schools per grade to receive either 300 gram cooked ALVs and school meal starch or the normal school meal as daily meal (5 days/weeks) for 3 months.

Locations

Country	Name	City	State
South Africa	Sizamela Intermediate School and Buffelsvlei Intermediate School	Rysmierbult	North West Province

Sponsors (6)

Lead Sponsor	Collaborator
North-West University, South Africa	Agricultural Research Council of South Africa, Medical Research Council, South Africa, National Research Foundation, South Africa, Program to Support Pro-poor Policy Development (PSPPD), Sight and Life

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nutritional status of school children (nutritional status measured by: blood haemoglobin, serum ferritin, serum zinc and serum retinol)		three months	Yes
Secondary	Change in nutritional status of school children (nutritional status measured by: height-for-age z-score, weight-for-age z-score and BMI-for-age z-score)		three months	No