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Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I)

This study has been completed.
Sponsor:
Collaborator:
The Mathile Institute for the Advancement of Human Nutrition
Information provided by:
Shoulder to Shoulder
ClinicalTrials.gov Identifier:
NCT01312987
First received: March 5, 2011
Last updated: July 31, 2011
Last verified: July 2011

March 5, 2011
July 31, 2011
March 2009
April 2010   (final data collection date for primary outcome measure)
  • Change from baseline in height at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Participating children were measured by trained staff every month during the 12 month intervention.
  • Change from baseline in hemoglobin status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Hemoglobin status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
  • Change from baseline in serum transferrin status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Serum transferritin was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
  • Change from baseline in C-Reactive Protein levels at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    C-Reactive Protein was measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention.
  • Change from baseline in weight at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Participating children were weighed by trained staff every month during the 12 month intervention.
  • Height and weight [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Participating children were measured and weighed by trained staff every other month during the 12 month intervention.
  • Hemoglobin status [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Hemoglobin status was measured from blood samples taken by finger pricks at baseline, month 3, month 6, and month 12 of the intervention.
  • Serum transferritin status [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Serum transferritin was measured from blood samples taken by finger pricks at baseline, month 3, month 6, and month 12 of the intervention.
  • Vitamin A status [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Vitamin A status was measured from blood samples taken by finger pricks at baseline, month 3, month 6, and month 12 of the intervention.
Complete list of historical versions of study NCT01312987 on ClinicalTrials.gov Archive Site
  • Change from baseline in zinc levels at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Zinc status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
  • Change from baseline in food insecurity status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Assessment teams administered a scored questionnaire at baseline and month 12 of the intervention.
  • Change from baseline in dietary intake based on 24-Hour Food Recall at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Assessment teams administered a 24-Hour Food Recall every month of the intervention.
  • Change from baseline in various health outcomes at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Assessment teams administered a scored questionnaire every month of the intervention.
  • Change from baseline in acceptability of nutrition supplement at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Assessment teams administered a scored questionnaire at baseline, month 6, and month 12 of the intervention
  • Change from baseline in folate status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Folate status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
  • Change from baseline in vitamin B12 status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Vitamin B12 was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
  • Zinc [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Zinc status was measured from blood samples taken by finger pricks at baseline, month 3, month 6, and month 12 of the intervention.
  • Food Insecurity status [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Assessment teams administer a scored questionnaire at baseline, month 3, month 6, and month 12 of the intervention.
  • Dietary intake based on 24-Hour Food Recall [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Assessment teams administer a 24-Hour Food Recall e at baseline, month 3, month 6, and month 12 of the intervention.
  • Health outcomes [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
  • Acceptability of nutrition supplement [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Assessment teams administer a scored questionnaire at baseline, month 3, month 6, and month 12 of the intervention
  • Folate status [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Folate status was measured from blood samples taken by finger pricks at baseline, month 3, month 6, and month 12 of the intervention.
  • Vitamin B12 status [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    Vitamin B12 was measured from blood samples taken by finger pricks at baseline, month 3, month 6, and month 12 of the intervention.
Not Provided
Not Provided
 
Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I)
Improving Nutrition and Health Outcomes in Intibuca, Honduras

The purpose of this research study is to assess what impact an integrated educational and feeding intervention delivered to infants and children has on growth (weight and height), development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory and diarrheal) outcomes. A randomized community trial was used to implement a nutrition intervention program consisting of monthly education sessions, a lipid-based nutrition supplement, and food vouchers for local staples.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Malnutrition
  • Undernutrition
Dietary Supplement: Lipid-based nutritional supplement

After gradual introduction of the lipid-based nutritional supplement, daily dose per child is as follows:

3 teaspoons 3 x day for children younger than 12 months 4.5 teaspoons 3 x day for children older than 12 months

Other Name: Plumpy'doz®
  • Experimental: Nutrition intervention
    Receives a month's supply of the nutrition supplement, Plumpy'doz®, in addition to food voucher for each month. Participants were also allowed to attend monthly educational sessions.
    Intervention: Dietary Supplement: Lipid-based nutritional supplement
  • No Intervention: Control
    Receives food vouchers each month.
    Intervention: Dietary Supplement: Lipid-based nutritional supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All healthy children between the ages of 5-18 months old and their mothers who are residents of the municipalities of Santa Lucia, Magdalena and San Antonio who do not present any of the medical conditions listed in the exclusion criteria.
  • Mothers have understood and signed consent forms to enable their children to participate in the study. They were willing to have their child participate in one or more blood draws, bi-monthly sessions: 1) nutrition classes and food voucher and lipid-based nutritional supplement and 2) height/weight monitoring, dietary intake questionnaire, and health outcome information. As well as the additional data assessments necessary to be considered active participants in the study.

Exclusion Criteria:

  • Children with congenital anomalies, mental retardation, severe physical handicap, under-nutrition caused by medical conditions that contribute to under-nutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, chronic diseases such as tuberculosis, etc.
  • Children with a known allergy to peanuts and eggs will also be excluded from the study, 30% of children with known allergies to nuts also have an allergy to eggs.
  • Plans to move or change their place of residence outside of the study region in the next 2 months would make them ineligible.
  • Mothers who are younger than 16 years of age will be excluded from the study. Women younger than 16 might not understand the consent process and the importance of following the guidelines established in the research, therefore we chose not to include this group as "eligible" participants.
  • Children who are <= -2 standard deviations below the norm for z score for weight for age. These children are severely malnourished and need to be carefully followed under the supervision of a qualified health care provider.
Both
5 Months to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01312987
MANI I, Shoulder to Shoulder
Yes
Jeff Heck, MD, Executive Director, Shoulder to Shoulder
Shoulder to Shoulder
The Mathile Institute for the Advancement of Human Nutrition
Principal Investigator: Jeff Heck, MD Shoulder to Shoulder
Shoulder to Shoulder
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP