- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01920646
Effect of African Leafy Vegetables on Nutritional Status of South African School Children. (ALV)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
North West Province
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Rysmierbult, North West Province, South Africa
- Sizamela Intermediate School and Buffelsvlei Intermediate School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ALV
300 gram cooked African leafy vegetables and school meal starch as daily school meal (5 days/weeks) for 3 months. Selected African leafy vegetables:Amaranthus cruentus (amaranth), Vigna unguiculata (cowpea), Cleome gynandra (spiderplant), and Cucurbita maxima (pumpkin). |
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.
|
|
No Intervention: Control
normal school meal as daily meal (5 days/weeks) for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in nutritional status of school children (nutritional status measured by: blood haemoglobin, serum ferritin, serum zinc and serum retinol)
Time Frame: three months
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
three months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Marius Smuts, PhD, North-West University
- Study Director: Annamarie Kruger, PhD, North-West University
- Principal Investigator: Marinka van der Hoeven, MSc, North-West University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALV study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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