Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03847662
Other study ID # CIFSRF 108124
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 3, 2016
Est. completion date June 5, 2018

Study information

Verified date February 2019
Source National Institute of Nutrition, Vietnam
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This repeated measures, cluster randomized, cohort trial design was carried out in three provinces in the northern mountainous area of Vietnam. Communes here were randomly selected for community based interventions with local production complimentary foods and marketing and distribution of fortified complimentary foods.


Description:

In rural northern Vietnam, childhood stunting rates are high. In Lào Cai province, female subsistence farmers grow crops, but face barriers sending produce to markets. The present intervention purchases local crops from local women subsistence farmers which are processed in local small-scale food processing facilities to produce instant fortified complementary foods for weaning.

Methods: A repeated measures survey was conducted from October to November 2016, with Caregiver-Child(<2y) pairs (n=800) in the provinces of Lai Chau, Lao Cai and Ha Giang. Anthropometric data of mother/child dyads was assessed and logistic regression analysis of stunted and underweight children explored associated factors. These included: core infant and young child feeding practices indicators, food insecurity, antenatal care check-ups, core water/sanitation, anemia and hygiene indicators.

This project leveraged the experience of the National Institute of Nutrition of Vietnam to ensure HACCP standards during manufacture. Locally grown rice was combined with a Zn/Fe premix before extrusion and hammer-milling. Local vegetables such as: "Sweet leaf" (Sauropus androgynous), pumpkin, Shiitake mushrooms (Lentinula edodes) and carrots were made into complimentary foods and sold locally.


Recruitment information / eligibility

Status Completed
Enrollment 799
Est. completion date June 5, 2018
Est. primary completion date June 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 2 Years
Eligibility Inclusion Criteria:

- Child participants must be younger than 2y at baseline.

- Caregivers must volunteer and were required to give informed written consent

Exclusion Criteria:

- Free from oedema

- Free from physical and mental disabilities

- Free from memory disorders and/or mental illness

Study Design


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
National Institute of Nutrition, Vietnam Global Affairs Canada, International Development Research Centre, Canada, Ryerson University

Outcome

Type Measure Description Time frame Safety issue
Primary Household Food Insecurity Access Scale Score from 1-27 indicating household food Insecurity. Where higher scores indicate greater food insecurity. This was taken at the beginning of intervention in Nov 2016 till completion in June 2018. Nov 2016-June 2018
Secondary Weight in kilograms Stunting (Height-for-age Z score <-2SD), Underweight (Weight-for-age Z score<-2SD), Wasting (Weight-for-height Z score<-2SD) compared with World Health Organization's growth charts. Nov 2016-June 2018
Secondary Height in Meters Stunting (Height-for-age Z score <-2SD), Underweight (Weight-for-age Z score<-2SD), Wasting (Weight-for-height Z score<-2SD) compared with World Health Organization's growth charts. Nov 2016-June 2018
Secondary Age in Months Stunting (Height-for-age Z score <-2SD), Underweight (Weight-for-age Z score<-2SD), Wasting (Weight-for-height Z score<-2SD) compared with World Health Organization's growth charts. Nov 2016-June 2018
Secondary Hemoglobin Levels of Children (<2y) Hemoglobin levels among Children participants assessed by finger prick blood sampling. Nov 2016-June 2018
See also
  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 NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation 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 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
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A
Completed NCT01458028 - Age and Gender Effects on the Pharmacokinetics of BAY85-3934 Phase 1