NCT01920646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

August 8, 2013

Last Update Submit

August 9, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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)

    three months

Study Arms (2)

ALV

EXPERIMENTAL

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).

Other: ALV

Control

NO INTERVENTION

normal school meal as daily meal (5 days/weeks) for 3 months

Interventions

ALVOTHER

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.

ALV

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sizamela Intermediate School and Buffelsvlei Intermediate School

Rysmierbult, North West, South Africa

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Marius Smuts, PhD

    North-West University

    STUDY DIRECTOR
  • Annamarie Kruger, PhD

    North-West University

    STUDY DIRECTOR
  • Marinka van der Hoeven, MSc

    North-West University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mrs Marinka van der Hoeven

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 12, 2013

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations