Clinical trial NCT01920646: Effect of African Leafy Vegetables on Nutritional Status of South African School Children.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Status
Vitamin A Status
Zinc Status
Malnutrition
Lead sponsor: North-West University, South Africa
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: Agricultural Research Council of South Africa
name: Sight and Life
name: Program to Support Pro-poor Policy Development (PSPPD)
name: National Research Foundation of South Africa
First posted: 2013-08-12
Enrollment: 171
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in nutritional status of school children (nutritional status measured by: blood haemoglobin, serum ferritin, serum zinc and serum retinol)
timeFrame: three months
Secondary outcomes:
measure: 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)
timeFrame: three months
Other outcomes:
Locations:
city: Rysmierbult
country: South Africa
facility: Sizamela Intermediate School and Buffelsvlei Intermediate School
state: North West Province
Study officials:
affiliation: North-West University
name: Marius Smuts, PhD
role: STUDY_DIRECTOR
affiliation: North-West University
name: Annamarie Kruger, PhD
role: STUDY_DIRECTOR
affiliation: North-West University
name: Marinka van der Hoeven, MSc
role: PRINCIPAL_INVESTIGATOR
References: