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.: PACTR202110646172601 Date of Approval: 22/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Vitamin D status in undernourished children
Official scientific title Vitamin D status in relation to systemic and intestinal inflammation in undernourished children, 6-59 months old
Brief summary describing the background and objectives of the trial Vitamin D deficiency and insufficiency have been reported to be prevalent in undernourished children, even in countries with sunshine all year round. Undernutrition in children is known to be associated with elevated systemic and intestinal inflammation, which in turn has been related to vitamin D status. Furthermore, vitamin D status could potentially be associated with iron status because of shared inflammatory mechanisms. This study aims to investigate the association of vitamin D status with systemic and intestinal inflammation, as well as iron status, in undernourished compared to apparently healthy non-malnourished children, 6-59 months. Vitamin D and biomarkers of inflammation and iron status will be assessed cross-sectionally in 175 children (125 undernourished and 50 non-malnourished) at clinics in the JB Marks area and vitamin D will be supplemented in a before-after study design in deficient and insufficient children.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ViDiMet SAM
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 30/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 175
Actual target sample size (number of participants) 175
Recruitment status Recruiting
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
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin D 50000 IU/ week for three weeks 21 days 50000 IU of Vitamin D in 1 mL of olive oil administered orally to undernourished children 125
Control Group Vitamin D 50000 IU/week for three weeks 21 days 50000 Vitamin D in 1 mL of olive oil administered orally to healthy non-malnourished comparison group 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Undernutrition group: MUAC < 12.5 cm and/ or weight-for-height, weight-for-age, height/length-for-age <-2 SD and or bilateral pitting oedema (+ or ++) Good appetite (passed appetite test) Clinically well and alert without medical complications Apparently healthy non-malnourished group: MUAC > 12.5 cm or WHZ > -1 SD but ≤ 2SD, Height-for-age > -1 SD Fever (ear temperature > 38 C) Persistent cough in the past 2 weeks Blood transfusion in the past month Medical record diagnosis of malabsorption syndrome Persistent diarrhoea or vomiting in the past 3 days Chronic medications including anticonvulsants (phenobarbital, carbamazepine, phenytoin), antibiotics (rifampicin, isoniazid), antiretroviral medications (protease inhibitors (PIs) and nonnucleoside reverse transcriptase inhibitors (NNRTIs); e.g. efavienz, darunavir and ritonavir Medical record diagnosis of conditions associated with vitamin D hypersensitivity (i.e. sarcoidiosis, primary hyperparathyroidism Children already receiving treatment for vitamin D deficiency Haemoglobin < 70 g/L Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 59 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 14/09/2021 North West University Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
11 Hoffman Street, Potchefstroom Potchefstroom 2520 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The association of vitamin D status with plasma IL6 and IL8 and intestinal fatty acid-binding protein in undernourished compared to apparently healthy non-malnourished children Baseline and 21-days post-supplementation
Secondary Outcome The relationship of vitamin D status with systemic (CRP and AGP) and intestinal inflammation (plasma intestinal fatty acid-binding protein) before and after three doses of 50,000 IU of vitamin D. Baseline and 21-days post supplementation
Secondary Outcome The relationship between vitamin D status and iron status markers (Hb, sTfR and ferritin) and status (ID, IDE, anaemia and IDA) before and after three doses of 50,000 IU of vitamin D Baseline and 21-days post-supplementation
Secondary Outcome To assess the association between vitamin D status and anthropometry (MUAC, weight, height/length, weight-for-height, weight-for-age, height-for-age z-scores) Baseline
Secondary Outcome To assess the association of systemic and intestinal inflammation with anthropometry (MUAC, weight, length/height, WAZ, WHZ and HAZ) Baseline
Secondary Outcome To assess the determinants of vitamin D status in undernourished and healthy children 6-59 months old, in the JB Marks municipality, North-West Province Baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Multiple community clinics in the JB Marks Municipality 11 Hoffman street Potchefstroom 2520 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Supporting Nutrition Research and Education in Africa 11 Hoffman street Potchefstroom 2520 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre of Excellence for Nutrition 11 Hoffman street Potchefstroom 2520 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Janet Carboo carboojane@gmail.com +27785256225 11 Hoffman street
City Postal code Country Position/Affiliation
Potchefstroom 2520 South Africa PhD Fellow North West University
Role Name Email Phone Street address
Principal Investigator Robin Dolman robin.dolman@nwu.ac.za +27828897053 11 Hoffman street
City Postal code Country Position/Affiliation
Potchefstroom 2520 South Africa Dietetics program leader North West University
Role Name Email Phone Street address
Scientific Enquiries Linda Malan linda.malan@nwu.ac.za +27844023834 11 Hoffman street
City Postal code Country Position/Affiliation
Potchefstroom 2520 South Africa Senior lecturer North West University
Role Name Email Phone Street address
Public Enquiries Martani Lombard tani.lombard@nwu.ac.za +27832854770 11 Hoffman street
City Postal code Country Position/Affiliation
Potchefstroom 2520 South Africa Senior lecturer North West University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial, after identification will be made accessible upon request Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date IPD will be shared upon request by researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information