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Completed

NCT Number: NCT01920646

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sizamela Intermediate School and Buffelsvlei Intermediate School

Rysmierbult, North West, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALV

Other

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.

Primary outcomes

  1. Change in nutritional status of school children (nutritional status measured by: blood haemoglobin, serum ferritin, serum zinc and serum retinol)

    Time frame: three months

Secondary outcomes

  1. 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)

    Time frame: three months

Sponsors and collaborators

Lead sponsor

North-West University, South Africa

Other

Collaborators

  • Agricultural Research Council of South Africa
  • Medical Research Council, South Africa
  • National Research Foundation of South Africa
  • Program to Support Pro-poor Policy Development (PSPPD)
  • Sight and Life

Registry information

Official study 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

Acronym: ALV

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 12, 2013
Registry last updated
Aug 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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