MalnutritionTSWAKANCT01845610
Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
A study testing Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese and Fortified fat-based paste with essential fatty acids in people with Malnutrition, run by North-West University, South Africa at 1 site in South Africa.
Trial summary
Complementary food supplements (CFS), fortified products that are mixed with the infant's usual complementary foods, have the potential to improve nutrition among infants. In Africa, maize is a major staple food used for complementary feeding. Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese and Fortified fat-based paste with essential fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteSouth Africa
- Study dates
- Sep 2013to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants resident in the study area
- Aged 6 months
Who cannot join
- Severe obvious congenital abnormalities
- Severe anaemia (haemoglobin < 70 g/L)
- Severe malnutrition (weight-for-length Z-score <-3.00)
- Other diseases referred for hospitalization by clinic staff
- Plans to move out of the study area in the next 7 months
- Known food allergies/intolerances e.g. to peanuts, milk and fish
Show all 9Show fewer
- Infants given special nutritional supplements
- Infants known to be HIV+
- Not been borne as a singleton
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Jouberton area of the greater Matlosana Municipality
Jouberton, North West
About this study
Complementary food supplements (CFS), fortified products that are mixed with the infant's usual complementary foods, have the potential to improve nutrition among infants. In Africa, maize is a major staple food used for complementary feeding. Compared to rice or wheat, maize has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit their absorption. The impact of CFS products in the context of a maize-based diet has not been well investigated. This study will test two newly developed fat-based CFS products made from soy.
The first product is a fortified fat-based spread that contains essential fatty acids with added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and zinc bioavailability. The second product is a fortified fat-based product containing essential fatty acids. Both products contain soy. The enrichment of the products with essential fatty acids is of particular interest in the South African context, as consumers are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high LA-containing sunflower oil during food preparation. The CFS products could contribute towards restoring the balance between LA and alpha-linolenic acid (ALA) intake.
The results of this study will provide evidence on whether or not two types of fortified CFS have the potential to address malnutrition (linear growth) and improve psychomotor development in infants. If proven effective, this approach of providing multiple nutrients can be made available to infants in the developing world and may lead to sustainable actions.
- Conditions
- Malnutrition
- Being tested
- Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese, Fortified fat-based paste with essential fatty acids
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganeseDietary supplement
Complementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese
Fortified fat-based paste with essential fatty acidsDietary supplement
Complementary food supplement fortified with micronutrients and essential fatty acids
| Study group | Role | What they receive |
|---|---|---|
| Fortified fat-based paste with EFAs, DHA, ARA and phytase | Experimental | Complementary food supplement providing micronutrients and both essential fatty acids, DHA, ARA, phytase and L-lysine, potassium, phosphorous, magnesium and manganese Receives: Dietary Supplement: Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese |
| Fortified fat-based paste with essential fatty acids | Experimental | Complementary food supplement providing micronutrients and essential fatty acids (EFAs) Receives: Dietary Supplement: Fortified fat-based paste with essential fatty acids |
| Control group | No intervention | The control group will receive a delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth by measuring length
To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control
Measured: 6 months
Secondary outcomes (3)
Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly)
To investigate the effects of two different fortified fat-based complementary food supplements on psycho-motor development of infants compared to a control group.
Measured: 6 months
Measures of anemia, essential fatty acid, iron and iodine status
To investigate the effects of two different fortified fat-based complementary food supplements on anemia, essential fatty acid, iron and iodine status of infants compared to a control group.
Measured: 6 months
Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end)
To assess the effects of two different fortified fat-based complementary food supplements on weight, MUAC and head circumference of infants
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startSep 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- North-West University, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- Global Alliance for Improved Nutrition, DSM Ltd, Unilever R&D
- Responsible party
- Principal investigator, Marius Smuts, North-West University, South Africa
- Investigators
- Cornelius M Smuts, PhD, Principal investigator, North-West University, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845610
- Sponsor's protocol ID
- TSWAKA
- Acronym
- TSWAKA
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2012
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smuts CM, Matsungo TM, Malan L, Kruger HS, Rothman M, Kvalsvig JD, Covic N, Joosten K, Osendarp SJM, Bruins MJ, Frenken LGJ, Lombard CJ, Faber M. Effect of small-quantity lipid-based nutrient supplements on growth, psychomotor development, iron status, and morbidity among 6- to 12-mo-old infants in South Africa: a randomized controlled trial. Am J Clin Nutr. 2019 Jan 1;109(1):55-68. doi: 10.1093/ajcn/nqy282.
PubMed 30649163
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
- ClinicalTrials.gov ID
- NCT01845610
- Acronym / sponsor ID
- TSWAKA / TSWAKA
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- North-West University, South AfricaUniversity, hospital or other
- Collaborators
- Global Alliance for Improved Nutrition, DSM Ltd, Unilever R&D
- Study start
- Sep 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complementary food supplements (CFS), fortified products that are mixed with the infant's usual complementary foods, have the potential to improve nutrition among infants. In Africa, maize is a major staple food used for complementary feeding. Compared to rice or wheat, maize has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit their absorption. The impact of CFS products in the context of a maize-based diet has not been well investigated. This study will test two newly developed fat-based CFS products made from soy.
The first product is a fortified fat-based spread that contains essential fatty acids with added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and zinc bioavailability. The second product is a fortified fat-based product containing essential fatty acids. Both products contain soy. The enrichment of the products with essential fatty acids is of particular interest in the South African context, as consumers are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high LA-containing sunflower oil during food preparation. The CFS products could contribute towards restoring the balance between LA and alpha-linolenic acid (ALA) intake.
The results of this study will provide evidence on whether or not two types of fortified CFS have the potential to address malnutrition (linear growth) and improve psychomotor development in infants. If proven effective, this approach of providing multiple nutrients can be made available to infants in the developing world and may lead to sustainable actions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fortified fat-based paste with EFAs, DHA, ARA and phytase | Experimental | Dietary Supplement: Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganeseComplementary food supplement providing micronutrients and both essential fatty acids, DHA, ARA, phytase and L-lysine, potassium, phosphorous, magnesium and manganese |
| Fortified fat-based paste with essential fatty acids | Experimental | Dietary Supplement: Fortified fat-based paste with essential fatty acidsComplementary food supplement providing micronutrients and essential fatty acids (EFAs) |
| Control group | No intervention | –The control group will receive a delayed intervention |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants resident in the study area
- Aged 6 months
Key exclusion criteria (9 listed)
- Severe obvious congenital abnormalities
- Severe anaemia (haemoglobin < 70 g/L)
- Severe malnutrition (weight-for-length Z-score <-3.00)
- Other diseases referred for hospitalization by clinic staff
- Plans to move out of the study area in the next 7 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganeseComplementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese | Dietary supplement | Fortified fat-based paste with EFAs, DHA, ARA and phytase |
| Fortified fat-based paste with essential fatty acidsComplementary food supplement fortified with micronutrients and essential fatty acids | Dietary supplement | Fortified fat-based paste with essential fatty acids |
Primary outcome
Linear growth by measuring length
Time frame: 6 months
To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control
3 secondary outcomes
Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly)
Time frame: 6 months
Measures of anemia, essential fatty acid, iron and iodine status
Time frame: 6 months
Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end)
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Derived from this study: PubMed 30649163Smuts CM, Matsungo TM, Malan L, Kruger HS, Rothman M, Kvalsvig JD, Covic N, Joosten K, Osendarp SJM, Bruins MJ, Frenken LGJ, Lombard CJ, Faber M. Effect of small-quantity lipid-based nutrient supplements on growth, psychomotor development, iron status, and morbidity among 6- to 12-mo-old infants in South Africa: a randomized controlled trial. Am J Clin Nutr. 2019 Jan 1;109(1):55-68. doi: 10.1093/ajcn/nqy282.
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelius M Smuts, PhD principal investigator
North-West University, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese and Fortified fat-based paste with essential fatty acids in people with Malnutrition, run by North-West University, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear growth by measuring length (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01845610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.