- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01751009
Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants. (vitapool)
A Randomised Controlled Home-based Trial of the Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kintampo, Ghana
- Kintampo North Municipality
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Informed consent of mother of eligible children aged 6-12 months.
Willingness to remain in the study area for entire duration of the study.
Willingness to agree to feed the child with supplied micronutrient supplements for duration of study.
The child should have started taking complementary foods in addition to breast milk.
Child's haemoglobin level of at least 70 g/L.
Exclusion Criteria:
Child's haemoglobin level less than 70 g/L.
Unable to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin A supplements
Sprinkles with Vitamin A
|
Sprinkles with Vitamin A
|
Active Comparator: Sprinkles without Vitamin A
Made of other micronutrients without Vitamin A
|
Active comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vitamin A status after 5 months supplementation
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
acceptability of home based fortified vitamin A supplements
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sherry Tanumihardjo, PhD, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IORG0004854
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 Malnutrition
-
HAN University of Applied SciencesFrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); SligroCompletedMalnutrition; Protein | Protein MalnutritionNetherlands
-
International Centre for Diarrhoeal Disease Research...GlaxoSmithKline; Stanford UniversityCompletedMalnutrition | Malnutrition in Children | Child MalnutritionBangladesh
-
University of Nove de JulhoUnknownMalnutrition, ChildBrazil
-
UNICEFSave the ChildrenCompletedSevere MalnutritionCongo, The Democratic Republic of the
-
International Centre for Diarrhoeal Disease Research...UNICEFNot yet recruitingMalnutrition SevereBangladesh
-
Action Against Hunger USAUniversity of Washington; Ethiopian Public Health InstituteNot yet recruitingModerate Acute Malnutrition | Severe Acute Malnutrition
-
Academy of Nutrition and DieteticsHartford Hospital; University of New Mexico; Meals on Wheels Central TexasNot yet recruiting
-
Diego MorettiSwiss Federal Institute of Technology; Wageningen University and Research; St... and other collaboratorsActive, not recruitingMalnutrition; ProteinSwitzerland
-
International Centre for Diarrhoeal Disease Research...CompletedProtein MalnutritionBangladesh
-
Microbiome Health Research InstituteUniversity of Cape TownTerminatedModerate Acute Malnutrition | Severe Acute MalnutritionSouth Africa
Clinical Trials on Vitamin A supplements
-
Sana'a UniversityUniversity of Malaya; Ministry of Health, MalaysiaCompletedAnemia | Malnutrition | Intestinal Parasitic InfectionsMalaysia
-
Ohio State University Comprehensive Cancer CenterRecruitingAllogeneic Hematopoietic Stem Cell Transplantation RecipientUnited States
-
Norwegian Institute of Public HealthNational Institute of Environmental Health Sciences (NIEHS)Completed
-
Eye and Vision Technologies and Research InstituteZeaVision, Inc.Unknown
-
University of GlasgowSuspendedDiet, Carbohydrate-restrictedUnited Kingdom
-
Institut de Recherche pour le DeveloppementUniversity of Copenhagen; Thrasher Research Fund; National Institute of Nutrition...CompletedMaking Maternal Post-partum Vitamin A Supplementation Effective: The Role of Timing and InflammationHealthy Women Giving Birth to Singleton InfantsVietnam
-
Johns Hopkins Bloomberg School of Public HealthUnited States Agency for International Development (USAID); Bill and Melinda... and other collaboratorsCompletedInfant Mortality | Vitamin A Deficiency | Maternal MortalityUnited States, Bangladesh
-
Sheba Medical CenterNot yet recruitingThe Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy
-
University GhentFlemish Interuniversity Council (VLIR); Arba Minch University, EthiopiaCompletedVitamin A Deficiency | Anemia, Iron Deficiency | Cognitive Development | Helminthic InfectionEthiopia
-
Shiraz University of Medical SciencesNot yet recruiting