HIV InfectionsNCT04995874
Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra
A study testing KOKOPlus protein and micronutrient powder in people with HIV Infections and Nutrition Poor, run by Noguchi Memorial Institute for Medical Research at 6 sites in Ghana.
Trial summary
The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in… Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Nutrition Poor, Child Development
- What is being tested?
- KOKOPlus protein and micronutrient powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 6 sitesGhana
- Study dates
- 6 Aug 2021to 25 Jun 2022
- 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 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother-infant dyads; HIV positive mothers and children between 6 and 12 months of age attending antiretroviral (ART) Clinics and child HIV Clinics.
Who cannot join
- Mothers who decline to participate in the study
- Children with severe acute malnutrition (mid-upper arm circumference <115 mm or a weight-for-height/length <-3 Z-scores of the WHO growth standards).
- Children on hospital admission
- Children with diagnosed or apparent congenital conditions such as encephalitis, cleft palate, hole in heart, which negatively affect the child's ability to eat and/or growth.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Ghana6 sites, 6 recruiting
- Recruiting
37 Military Hospital
Accra, Greater Accra Region
Philip Nyinaku, +233244780608, Nyinakup@yahoo.com
- Recruiting
Greater Accra Regional Hospital
Accra, Greater Accra Region
Salomey Frimpong, +233244038803, stfrimpong23@yahoo.com
- Recruiting
Korle-bu Teaching Hospital
Accra, Greater Accra Region
Joycelyn Assiment Dame, +233244251126, joycelyndame1@gmail.com
- Recruiting
Princess Marie Louise Children's Hospital
Accra, Greater Accra Region
Margaret Niezer, +233244290394, niezermargaret@yahoo.com
- Recruiting
Ashaiman Polyclinic
Ashaiman, Greater Accra Region
Adwoa Amoako, +2336300899, adkonadu@yahoo.co.uk
- Recruiting
Tema General Hospital
Tema, Greater Accra Region
Richard Anthony, +233244273212, kaniagha@yahoo.com
About this study
The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in Accra
Read the detailed description
The specific objectives are to accomplish the following
- To test the effectiveness of KOKOPlus to improve the nutritional status of HIV exposed infants aged 6-18 months.
- To measure and compare nutritional status in intervention and control arms by monitoring growth in terms of height and weight over the period of 6 months
- To measure and compare micronutrient status of intervention and control arms by comparing baseline midline and endline measurements of hemoglobin levels.
- To measure and compare morbidity rates of intervention and control arms.
- To measure and compare rates of achievement of child development goals between intervention and control arms using a standardized tool, the Caregiver Reported Early Development Instrument (CREDI).
- To understand and record experiences relating to the use of KOKOPlus of mothers/caregivers in the intervention arm through focus group discussion
- Conditions
- HIV Infections, Nutrition Poor, Child Development
- Being tested
- KOKOPlus protein and micronutrient powder
- Keywords
- HIV-Exposed, Nutrient Status, KOKOPlus
- Medical subject headings
- HIV Infections, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOKOPlus protein and micronutrient powderDietary supplement
KokoPlus, a complementary food supplement was formulated by using linear programming methodology to improve the protein quality as well as the micronutrient and macronutrient content of commonly consumed traditional complementary (baby) foods in Ghana . It contains soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix. It complies with WHO's complementary feeding guidelines, FAO/WHO recommended micronutrient intake (RNI) and the WHO's guidelines for protein and essential amino acid intake for children in the age group of 6 to 24 months. A daily supply of KokoPlus achieves 30% of the total recommended energy, 60% of total protein and 40% of total fat requirements from complementary foods. It also meets 35-55% of minimum intake of essential amino acids and 50-150% RNI based on the total daily requirements.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | KOKOPlus protein and micronutrient powder , a complementary food supplement containing soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix was formulated. Two weeks' supply of KOKOPlus sachets will be given to intervention arm participants every fortnight for 6 months to be mixed into any cereal, soup, stew, or other food given to the children. Receives: Dietary Supplement: KOKOPlus protein and micronutrient powder |
| Control | No intervention | This arm will receive no supplement and no placebo for the duration of the study., |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometry
Length-for-age Z score, Weight-for-age Z score. Weight for length Z score
Measured: 6 months
Haemoglobin
(g/dl), anaemia
Measured: 6 months
Child developmental Milestones achieved
Measured: 6 months
Secondary outcomes (1)
Morbidity
Incidence of fever, malaise, loss of appetite
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start6 Aug 2021
- Primary completion25 Jun 2022 (estimated)
- Study completion25 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 649 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noguchi Memorial Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- International Food Policy Research Institute
- Responsible party
- Sponsor
- Investigators
- Gloria K Folson, Principal investigator, Noguchi Memorial Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995874
- Sponsor's protocol ID
- 2021X018.NMI
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra
- ClinicalTrials.gov ID
- NCT04995874
- Acronym / sponsor ID
- 2021X018.NMI
- Conditions
- HIV Infections, Nutrition Poor, Child Development
- Keywords
- HIV-Exposed, Nutrient Status, KOKOPlus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 649 participants (estimated)
- Lead sponsor
- Noguchi Memorial Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- International Food Policy Research Institute
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 25 Jun 2022 (estimated)
- First posted
- 9 Aug 2021 (actual)
- 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.
The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in Accra
Detailed description
The specific objectives are to accomplish the following
- To test the effectiveness of KOKOPlus to improve the nutritional status of HIV exposed infants aged 6-18 months.
- To measure and compare nutritional status in intervention and control arms by monitoring growth in terms of height and weight over the period of 6 months
- To measure and compare micronutrient status of intervention and control arms by comparing baseline midline and endline measurements of hemoglobin levels.
- To measure and compare morbidity rates of intervention and control arms.
- To measure and compare rates of achievement of child development goals between intervention and control arms using a standardized tool, the Caregiver Reported Early Development Instrument (CREDI).
- To understand and record experiences relating to the use of KOKOPlus of mothers/caregivers in the intervention arm through focus group discussion
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: KOKOPlus protein and micronutrient powderKOKOPlus protein and micronutrient powder , a complementary food supplement containing soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix was formulated. Two weeks' supply of KOKOPlus sachets will be given to intervention arm participants every fortnight for 6 months to be mixed into any cereal, soup, stew, or other food given to the children. |
| Control | No intervention | –This arm will receive no supplement and no placebo for the duration of the study., |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Mother-infant dyads; HIV positive mothers and children between 6 and 12 months of age attending antiretroviral (ART) Clinics and child HIV Clinics.
Key exclusion criteria (4 listed)
- Mothers who decline to participate in the study
- Children with severe acute malnutrition (mid-upper arm circumference <115 mm or a weight-for-height/length <-3 Z-scores of the WHO growth standards).
- Children on hospital admission
- Children with diagnosed or apparent congenital conditions such as encephalitis, cleft palate, hole in heart, which negatively affect the child's ability to eat and/or growth.
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 |
|---|---|---|
| KOKOPlus protein and micronutrient powderKokoPlus, a complementary food supplement was formulated by using linear programming methodology to improve the protein quality as well as the micronutrient and macronutrient content of commonly consumed traditional complementary (baby) foods in Ghana . It contains soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix. It complies with WHO's complementary feeding guidelines, FAO/WHO recommended micronutrient intake (RNI) and the WHO's guidelines for protein and essential amino acid intake for children in the age group of 6 to 24 months. A daily supply of KokoPlus achieves 30% of the total recommended energy, 60% of total protein and 40% of total fat requirements from complementary foods. It also meets 35-55% of minimum intake of essential amino acids and 50-150% RNI based on the total daily requirements. | Dietary supplement | Intervention |
Primary outcome
Anthropometry
Time frame: 6 months
Length-for-age Z score, Weight-for-age Z score. Weight for length Z score
Haemoglobin
Time frame: 6 months
(g/dl), anaemia
Child developmental Milestones achieved
Time frame: 6 months
1 secondary outcome
Morbidity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Gloria K Folson principal investigator
Noguchi Memorial Institute for Medical Research
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOKOPlus protein and micronutrient powder in people with HIV Infections and Nutrition Poor, run by Noguchi Memorial Institute for Medical Research at 6 sites in Ghana.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Ghana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gloria K Folson (+233550006053, gfolson@noguchi.ug.edu.gh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometry (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2021.