- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01840384
Efficacy Study of Multiple Micro Nutrients Supplementation (Babytop)
Longitudinal Study on the Effect of Multiple Micro Nutrients Supplementation on Haemoglobin Level of 8 to 22-month-old Indonesian Children.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tonny Sundjaya, MD
- Email: tonny.sundjaya@danone.com
Study Locations
-
-
-
Jakarta, Indonesia
-
Contact:
- Dian Novita Chandra, MD, MSc
-
Principal Investigator:
- Rini Sekartini, MD, PhD
-
Sub-Investigator:
- Saptawati Bardosono, MD, MSc, PhD
-
Sub-Investigator:
- Tjhin Wiguna, MD
-
Sub-Investigator:
- Dian Novita Chandra, MD, MSc
-
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Apparently healthy Indonesian infants
- Age 8-10 month at baseline visit
- Willing to take 2 sachets of study product per day
- Planning to reside in the study area during the next 14-16 months
- Written informed consent by parent(s) or legally acceptable representative (in ICF there is statement that both are agree that child participate in the study)
Exclusion Criteria:
- Haemoglobin < 8 g/dL at screening visit*.
- Significant congenital abnormality which according to investigator's clinical judgement will interfere the study conduct and assessment
- Any known conditions likely to affect nutrient absorption diagnosed by the child's physician
- Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special formula is required).
- Any other current or previous illnesses/conditions or intervention which according to investigator's clinical judgement could interfere the study conduct and assessment (e.g. chronic illness or physical or mental handicaps)
- Regular use of MMN supplements syrup (every day in > 1 week) within two weeks prior to entry into the study.
- Not intending to use micronutrient supplements during the study
- Participation in any other studies involving similar investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Premature birth (gestational age <37 weeks)
- Low birth weight (< 2500 g)
Severely under nutrition indicated by any of the following criteria: severely stunted: HAZ < -3 SD; severely underweight WAZ <-3 SD; wasted: WHZ <-2 SD
*Subject with haemoglobin level (finger prick blood sample) at screening visit between 8-10 g/dL will be given iron syrup supplementation for 1 month. Thereafter, haemoglobin level (whole blood sample) will be checked at baseline visit:
- If Hb > 10 g/dL, subject is eligible for randomisation
- If Hb < 10 g/dL, subject is not eligible for randomisation and will be given iron syrup supplementation for 2 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Multi-micronutrients
|
|
PLACEBO_COMPARATOR: Maltodextrin and Lactose
Placebo contained maltodextrin and lactose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Haemoglobin level
Time Frame: 12 months
|
Change in serum haemoglobin level after 12 months of intervention
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anemia prevalence
Time Frame: 12 months
|
Change in anemia prevalence from baseline to after 12 months of intervention
|
12 months
|
Anthropometric
Time Frame: 24 months of age
|
Change in anthropometric measurements from baseline until 24 months of age
|
24 months of age
|
Micronutrients
Time Frame: 12 months
|
Change in selected micronutrients status from baseline to after 12 months of intervention
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rini Sekartini, MD, PhD, Medical Research Unit, Faculty of Medicine, University of Indonesia
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT.01.2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia, Iron-deficiency
-
Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
-
Luzerner KantonsspitalRecruitingIron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron DeficienciesSwitzerland
-
Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
-
Children's Hospital Los AngelesWithdrawnAnemia | Iron-deficiency Anemia | Healthy ControlsUnited States
-
Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
-
Iowa State UniversityCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron Deficiency Anaemia Due to Dietary CausesUnited States
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
Clinical Trials on Multi-micronutrients
-
McMaster UniversityNot yet recruitingOxidative Stress | Radiation Exposure | DNA Damage, Radiation Induced
-
Barts & The London NHS TrustImperial College LondonNot yet recruitingAortic Stenosis | Frailty
-
University of North Carolina, Chapel HillTerminatedRotator Cuff/Shoulder Structure and FunctionUnited States
-
Tufts UniversityMB Clinical Research and Consulting LLCCompletedNutrient DeficiencyUnited States
-
The First Affiliated Hospital of Soochow UniversityNot yet recruitingNausea and Vomiting, Aspiration, Intraoperative
-
McMaster UniversityAlberta Health services; Hamilton Health Sciences Corporation; London Health... and other collaboratorsRecruiting
-
Cardialen, Inc.Genae; Five CornersTerminatedVentricular Fibrillation | Ventricular TachycardiaAustralia
-
Germans Trias i Pujol HospitalFundació Institut Germans Trias i PujolUnknownSurgical Wound | Knee DiseaseSpain
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingInfertility, Female | Fertility Disorders
-
Medical University of ViennaCompleted