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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201702001947398 Date of Registration: 29/12/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title BKF6006
Official scientific title A randomized, double-blind, placebo-controlled trial of Vitamin A plus Zinc or placebo in school children aged 7-12 years
Brief summary describing the background and objectives of the trial Micronutrient deficiencies among under-five year old children is probably one of the most studied topics in the nutrition field among children of developing countries. A larges series of community-based randomized controlled trials have shown that improving nutritional status including micronutrients as well, of these children in such regions, reduce morbidity and mortality. Because vitamin A and zinc are both critical for immune system function and their deficiencies usually coexistent in young children and school children as well in low-income countries, combined supplementation represents an approach to contribute to the prevention and treatment of infectious disease in these children. To date, little of such study has been conducted to assess whether this combination will effectively prevent parasite infestation. Consistent information¿s from animal model studies have shown that zinc deficiency might have an impaired impact of vitamin A whether the livers stock or at plasma level. Few studies in human have focused on such interaction and existing data are often inconclusive. A study that adequately powered, and that uses sophisticated measures of vitamin A and zinc status in a population with these micronutrients deficiencies would contribute to such knowledge, while contributing also in resolving an important public health issue. It will also help to assess the proportion of vitamin A and zinc deficiencies among school children and to determine how can these micronutrients supplementation may help to reduce intestine parasites morbidity in a context of rural Burkina Faso We anticipate that the combination of vitamin A and zinc will result in a 50% reduction in intestine parasites infestation while concomitantly reducing anemia (25% reduction). This study will contribute to advocate for the combination of vitamin A and zinc supplementation among school children. The proposed work will be co-funded up to now by the International Atomic Energy Agency.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,NUTRITION,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied intestine parasites infestation
Purpose of the trial Prevention
Anticipated trial start date 01/10/2013
Actual trial start date 03/03/2014
Anticipated date of last follow up 31/07/2014
Actual Last follow-up date 08/08/2014
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 196
Recruitment status Stopped early/ terminated
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 Randomised Simple randomisation using a radomisation table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Zinc group 15 mg of zinc per day four months Vitamin A (200000 IU) at baseline plus zinc 6 times per week 100 Active-Treatment of Control Group
Control Group comparison group one capsule of placebo per day four months Vitamin A (200000 IU) at baseline plus zinc 6 times per week 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
School children aged 7-12 years Informed consent signed for each child Child¿s family resident in the study areas Clinical evidence of vitamin A deficiency Severe anemia defined as <7 g/L Severe malnutrition Serious illnesses Child aged <6 years or >12 years 7 Year(s) 12 Year(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 27/01/2014 Comité d'Ethique Institutionnel du Centre MURAZ
Ethics Committee Address
Street address City Postal code Country
Avenue Mamadou Konaté BOBO DIOULASSO 01 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of clinical intestinal parasites -analysis of stools at baseline -analysis of stools at endline
Secondary Outcome changes in weight and height -weight of each child at baseline -weight of each child at endline -height of each child at baseline -height of each child at endline
Secondary Outcome vitamin A and zinc nutritional status -vitamin A and zinc concentrations at baseline -vitamin A and zinc concentartions at endline
Secondary Outcome prevalence of anemia -heamoglobin concentration for each child at baseline -heamoglobin concentration for each child at endline
Secondary Outcome incidence of malaria -malaria parasites at baseline -malaria parasites at endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ecole primaire A, CP2 RN9 BAMA 01 Burkina Faso
Ecole primaire A CE 2 RN9 BAMA 01 Burkina Faso
Ecole primaire A, CE1 RN9 BAMA 01 Burkina Faso
Ecole primaire A, CP1 RN9 BAMA 01 Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
International Atomic Energy Agency (IAEA) 1400 Vienna Vienna PO Box 100 Austria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Atomic Energy Agency (IAEA) 1400 Vienna Vienna 01 Austria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Sherry Tanumihardjo 1415 Linden Drive Madison 53706 United States of America
Ouedraogo Jean Bosco Avenue de la Liberté Bobo Dioulasso 01 Burkina Faso
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Augustin N Zeba nawidzeba@gmail.com +22620981880 Avenue de la Liberté
City Postal code Country Position/Affiliation
Bobo Dioulasso 01 Burkina Faso Nutrition unit responsible at IRSS
Role Name Email Phone Street address
Public Enquiries JEAN FIDELE BATIONO jeanfidelebationo@gmail.com +22670747906 Avenue Mamadou Konate
City Postal code Country Position/Affiliation
Bobo Dioulasso 01 Burkina Faso Biochemistry Lab Responsible
Role Name Email Phone Street address
Scientific Enquiries Sherry TANUMIHARDJO sherry@nutrisci.wisc.edu +1 608-265-0792 1415 Linden Dr.
City Postal code Country Position/Affiliation
Madison WI 53706 United States of America Director of the Undergraduate Certificate in Global Health
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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