Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202002576768667 Date of Approval: 25/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Child acceptability of homemade complementary food blend made from pumpkin and common bean in Uganda
Official scientific title Nutrition and sensory properties of a complementary food prepared from pumpkin and common bean in Uganda
Brief summary describing the background and objectives of the trial Homemade complementary foods (CFs) fed to children in Uganda are usually devoid of vitamin A, iron and zinc. Novel homemade CFs rich in vitamin A, iron and zinc need to be developed, and assessed for their acceptability among target children. Common bean is a rich source of iron and zinc, whilst pumpkin is a rich source of provitamin A carotenoids. Therefore, this study selected common bean and pumpkin locally cultivated in rural Uganda for use in the home preparation of a novel PVAC, iron and zinc rich complementary food (CF), common bean pumpkin blend (BPB) and the control, Pumpkin blend (PB).Child acceptability is assessed by feeding the novel CF to the child, followed by measuring the amount of CF consumed, and duration taken to complete the CF. The primary objective was to measure the amount of CF consumed by children. The two secondary objectives were to measure the time taken by the child to consume the served CF; and to analyse the PVAC, iron and zinc intake of each child based on the amount of CF consumed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 08/01/2020
Actual trial start date 08/01/2020
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date 22/01/2020
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Common Bean Pumpkin Blend 100 grams, once One day 35 Children were offered Common Bean Pumpkin Blend (BPB) at least 1 hour after they were last fed before crossing over to control arm. 100 grams of complementary food was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow. 35
Control Group Pumpkin Blend 100g given once one day 35 Children were offered Pumpkin Blend (PB) at least 1 hour after they were last fed before crossing over to intervention arm. 100 grams of BP was offered to the child in a serving dish by the caregiver. The amount of food ingested was calculated by subtracting the left-over from the offered amount. Pre-weighed napkins were provided; any food that was regurgitated, vomited or spilled was swabbed, the napkin weighed and subtracted from the weight of the amount offered. Duration of feeding was measured as described elsewhere. Caregivers were asked to spoon feed their children the assigned CF until the child refused to eat. After a two-minute pause, the same food was offered a second time until s/he refused again. After a second two-minute pause, the food was offered a third time until refused again. After this third refusal, the feeding episode was considered terminated. The duration of the feeding (excluding the intervening ‘pause periods’) was recorded by stopwatch, and the total duration of the feeding was noted. The feeding episode took place under the direct supervision of a trained research assistant to ensure that feeding was not forced. Children were considered as refusing intake if they moved their head away from the food, cried, clamped the mouth shut or clenched the teeth, or became agitated, spat out the food or refused to swallow. 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children age 6 to 24 months old On complementary feeding Caregivers give consent for their children to participate Weight for age or weight for height z-score was < −3 (severe acute malnutrition) childhood acute illness or features suggestive of any chronic disease such as tuberculosis Any congenital anomalies such as cleft lip or palate that would prevent child to feed. Infant: 1 Month-23 Month 6 Month(s) 24 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/09/2019 The Aids Support Organisation Uganda
Ethics Committee Address
Street address City Postal code Country
Mulago Hospital Complex Mulago Kampala 00256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of complementary food consumed by the child once, at the end of feeding
Secondary Outcome Duration taken for the child to consume the given complementary food once, at the end of feeding
Secondary Outcome Vitamin A, iron and zinc intake depending on the amount of complementary food consumed by the child. once, at end of feeding
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ntwetwe Health Centre IV Ntwetwe Town Council Kyankwanzi District Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Health Economics and HIV AIDS Research Division University of KwaZulu Natal Westville Campus J Block 4th Floor Durban 4041 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Health Economics and HIV AIDS research Division University of KwaZulu Natal South Africa Westville Campus J Block 4th floor Durban 4041 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Kirthee Pillay University of Kwa-Zulu Natal Private Bag X01, Scottsville 3209, Pietermaritzburg 3201 Pietermaritzburg South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edward Buzigi edwardbuzigi@gmail.com +256772867437 Kyambogo University P. O Box 1
City Postal code Country Position/Affiliation
Kyambogo Kampala 00256 Uganda University Lecturer Department of Human Nutrition Kyambogo University
Role Name Email Phone Street address
Scientific Enquiries Kirthee Pillay pillayk@ukzn.ac.za +27837853072 Scottsville 3209, Pietermaritzburg 3201,
City Postal code Country Position/Affiliation
Scottsville Pietermaritzburg 3209 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Yunia Nakaggwa nakaggway@gmail.com +256772321871 Ntwetwe Health Center IV
City Postal code Country Position/Affiliation
Ntwetwe Town Council Uganda Research Administrator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial, after de-identification Clinical Study Report Between January and December 2020 Any one who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No website Yes The mean consumption of BPB and PB was 53.9g and 54.4g, respectively. The mean duration for consumption of BPB and PB was 20.6 and 20.3 minutes, respectively. There was no significant difference in amounts consumed, and duration of consumption in BPB and PB (P>0.05). The mean intake of vitamin A was significantly higher (P<0.00001) in PB (152.5 µgRAE) compared to BPB (100.9 µgRAE). The mean iron intake was significantly higher in BPB (1.1mg) (P<0.00001) compared to BP (0.3mg). Furthermore, zinc intake was significantly higher (P<0.00001) in BPB (0.58mg) compared to BP (0.13mg). 31/03/2020 31/03/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks No link
Changes to trial information