Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02571764
Other study ID # PEP-1409
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date September 2017

Study information

Verified date September 2018
Source PepsiCo Global R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children with moderate acute malnutrition will be recruited in order to receive an intervention which consists in the consumption of a single serving of SF-cookies daily, 7-days a week for 12 months and 12 educational sessions on health and nutrition.


Recruitment information / eligibility

Status Completed
Enrollment 248
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years to 5 Years
Eligibility Inclusion Criteria:

- Children (2-5 years old), who are from low socioeconomic classes (E and D classes),

- reside in rural areas, and with WHZ- between > -3 and = -2, and

- informed consent given by the subject's mother or caregiver

Exclusion Criteria:

- Severe acute malnutrition (HAZ, WAZ and WHZ-scores =-3) based on the 2006 World Health Organization (WHO) reference values (24)

- Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)

- (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).

- Current consumption of other supplementary foods.

- Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nutritional Oats Cookie


Locations

Country Name City State
Mexico Un Kilo de Ayuda Colonia Lomas De Chapultepec Distrito Federal

Sponsors (1)

Lead Sponsor Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight (kg) for height (cm) Z-score 12 months
Secondary Weight (kg) gains 12 months
Secondary height (cm) for age (months) Z-score 12 months
Secondary weight (kg) for age (months) Z-score 12 months
Secondary Mid-upper arm circumference (cm) (MUAC) 12 hours
Secondary height (cm) gain 12 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06056089 - Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM) N/A
Not yet recruiting NCT06038071 - Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC) N/A
Recruiting NCT06002438 - Eggs for Gut Health N/A
Completed NCT02272543 - Acceptability and Efficacy of 'Fish Surimi Peptide' in Under Five Children Suffering From Moderate Acute Malnutrition Phase 1
Not yet recruiting NCT06045104 - Alternative Feeding Regimen on Recovery of Children Aged 6-59 Months With Moderate Acute Malnutrition in Bangladesh. N/A
Recruiting NCT06214897 - Choline to Prevent SAM in Children With MAM N/A
Completed NCT03751475 - Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo N/A
Completed NCT01115647 - Treating Moderate Malnutrition in 6-24 Months Old Children N/A
Completed NCT03474276 - Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old Phase 3
Completed NCT01898871 - Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition Phase 2
Completed NCT01147198 - Ready to Use Supplementary Food in Moderate Childhood Malnutrition N/A
Not yet recruiting NCT06305442 - Microbiota Directed Food for Children With Moderate Acute Malnutrition N/A
Terminated NCT03087097 - Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in the Rehabilitative Phase of Malnutrition Phase 1
Completed NCT03146897 - Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition N/A