Anemia Clinical Trial
Official title:
Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial
NCT number | NCT00629629 |
Other study ID # | vitolo2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2001 |
Est. completion date | May 2015 |
Verified date | October 2022 |
Source | Federal University of Health Science of Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers of the intervention group received dietary counseling in the first year of life. Both groups received routine care by their paediatricians and research assessment at 6 and 12 months, 4 years, 8 years and 12 years of age.
Status | Completed |
Enrollment | 500 |
Est. completion date | May 2015 |
Est. primary completion date | October 2002 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Newborn infants with birth weight = 2.500 g and gestational age = 37 weeks were considered eligible for the study. Exclusion Criteria: - HIV-positive mothers - Congenital malformation - Infants referred to intensive care unit - Multiple pregnancy. |
Country | Name | City | State |
---|---|---|---|
Brazil | Household | São Leopoldo | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Federal University of Health Science of Porto Alegre | Conselho Nacional de Desenvolvimento Científico e Tecnológico |
Brazil,
Feldens CA, Vítolo MR, Drachler Mde L. A randomized trial of the effectiveness of home visits in preventing early childhood caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):215-23. — View Citation
Vitolo MR, Bortolini GA, Feldens CA, Drachler Mde L. [Impacts of the 10 Steps to Healthy Feeding in Infants: a randomized field trial]. Cad Saude Publica. 2005 Sep-Oct;21(5):1448-57. Epub 2005 Sep 12. Portuguese. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of a nutrition advice programme in exclusive breastfeeding. | Group difference in months of esclusive breastfeeding | 1 year | |
Primary | Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 1 year | |
Primary | Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 4 years | |
Primary | Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 8 years | |
Primary | Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 12 years | |
Secondary | Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization. | Group differences in the % of children with each condition | 1 year | |
Secondary | Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 1 year | |
Secondary | Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 4 years | |
Secondary | Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 8 Years | |
Secondary | Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 12 Years | |
Secondary | Salty taste preferences | Evaluate the most preferred concentration of salt | 12 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03341338 -
Genes-in-Action - Hepcidin Regulation of Iron Supplementation
|
||
Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
Not yet recruiting |
NCT06309641 -
Methemoglobinemia Following Intravenous Iron Treatment
|
||
Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
Completed |
NCT02912533 -
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Completed |
NCT03822884 -
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02603250 -
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
|
N/A | |
Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
Withdrawn |
NCT01934842 -
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
|
N/A | |
Completed |
NCT02310113 -
Transfusion and Skeletal Muscle Tissue Oxygenation
|
N/A | |
Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
Completed |
NCT01693029 -
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
|
Phase 3 | |
Completed |
NCT01458028 -
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
|
Phase 1 | |
Completed |
NCT01432717 -
Study of ACE-536 in Healthy Postmenopausal Women
|
Phase 1 |