Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/08/2015
Date assigned
02/09/2015
Last edited
02/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Severe acute malnutrition (SAM) is defined by the World Health Organisation (WHO) as a very low weight for height, an appearance of wasting away (wasting), or by the presence of nutritional oedema (swelling caused by a build-up of excess fluid in the body). When people are malnourished, the body’s metabolism adapts to the lack of nutrients in order to survive, and levels of vitamins and minerals in the body go down. When starving people are re-fed, the body uses more of a mineral called phosphate, as this is needed for turning sugars in the diet into energy. If they are given diets with too much energy too soon then levels of phosphate in the body can become dangerously low as they are used up (re-feeding hypophosphataemia), which can be seriously damaging to health. Special diets have now been introduced which are fortified with phosphates in order to try to prevent re-feeding hypophosphataemia, but the effects of this have not been fully investigated. This study aims to monitor the amount of phosphorus in the blood plasma (P-phosphate) in children being treated for SAM during the re-feeding programme.

Who can participate?
Children admitted to Mwanamugimu Nutrition Unit (Uganda) with signs of SAM.

What does the study involve?
Children who are receiving treatment as an in-patient for SAM are given a therapeutic milk diet. The children are started on Formula 75 (F-75), which includes 75 calories per 100 ml. The F-75 therapeutic milk has been designed to meet the child's needs without overwhelming the body's systems at the start of treatment. The children are then moved onto Formula 100 (F-100) which contains 100 calories per 100 ml. The amount of P-phosphate is measured on admission, at the second day of treatment, at the start of the F-100 treatment, two days later and then at discharge.

What are the possible benefits and risks of participating?
The main benefit of participating in the study is the improved care provided. There are no risks of participating in the study.

Where is the study run from?
Mwanamugimu Nutrition Unit (Uganda)

When is the study starting and how long is it expected to run for?
October 2012 to May 2013

Who is funding the study?
1. University of Copenhagen (Denmark)
2. Augustinus Fonden (Denmark)
3. Lundbeckfonden (Denmark)
4. Brødrene Hartmanns Foundation (Denmark)
5. Arvid Nielsens Foundation (Denmark)
6. Axel Muusfeldts Foundation (Denmark)
7. Aase and Einar Danielsens Foundation (Denmark)
8. Torkild Steenbecks Scholarship (Denmark)

Who is the main contact?
Professor Henrik Friis

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henrik Friis

ORCID ID

http://orcid.org/0000-0002-2848-2940

Contact details

Rolighedsvej 30
Frederiksberg
1957
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Re-feeding of children hospitalized with severe acute malnutrition: an observational study from Mwanamugimu Nutrition Unit, Uganda

Acronym

FeedSAM

Study hypothesis

The underlying study hypothesis is that children with severe acute malnutrition (SAM) have derangement of phosphorus and other electrolytes, and that these are not adequately corrected by current treatment, and hence delay or prevent recovery of nutritional status and essential body functions.

Primary objective: To assess changes in serum phosphate during treatment of children with SAM with therapeutic milk.
Secondary objectives: To assess changes in and/or predictors of anthropometry, clinical characteristics, child development and physical activity, blood essential fatty acids, immune factors, gut permeability and flora, heart function, and mortality.

Ethics approval

1. Research Ethics Committee Makerere University (Uganda), 08/08/2012, ref: 2012-134
2. The National Committee on Health and Research Ethics (Denmark), 20/08/2012, ref: 1208653

Study design

Single-centre observational cohort study with nested cross-sectional study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Severe acute malnutrition (SAM) in children

Intervention

There was no experimental intervention. All study participants received in-patient treatment for complicated severe acute malnutrition according to standard protocols based on international guidelines. Uganda follows the approach stated in the Integrated Management for Acute Malnutrition. The treatment is based on therapeutic milk diets (F-75 and F-100) to children hospitalized with SAM, and treating medical complications. A child is considered to have SAM if it has either weight for height (W/H) below the -3 standard deviations (SD) or mid upper arm circumference (MUAC) below the cut-off points for SAM or pitting oedema developing from both feet. In accordance with treatment guidelines, the duration of treatment with F-75 and F-100, and hence the follow-up time points, depended on the treatment response.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Plasma phosphate was measured at five time points: on admission, the second day of treatment, the start of the transition to F-100, day two of transition and at discharge.

Secondary outcome measures

1.Blood essential fatty acids at admission, transition, discharge, 8 weeks, 16 weeks
2. Physical activity using accelerometers at discharge
3. Child development using the Malawi Development assessment tool at admission, transition, discharge, 8 weeks, 16 weeks
4. Thymus size using ultrasound at admission, discharge and week 8)
5. T-cell subsets and cytokines using flow cytometry at admission and discharge
6. Gut permeability (LM-test) at admission and discharge
7. Gut flora and pathogens at admission and discharge
8. Myocardial function and biomarkers at admission and discharge
9. Mortality during admission

Overall trial start date

01/10/2012

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children between 6 - 59 months of age
2. Admitted to Mwanamugimu Nutrition Unit paediatric wards with either:
2.1 Weight for height (W/H) below the -3 standard deviations (SD) and mid upper arm circumference (MUAC) below the cut-off points for SAM
2.2. Pitting oedema developing from both feet
3. Living near the study centre

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Children with shock, severe respiratory difficulty or significant bleeding at the time of admission
2. Weight below 4.5 kg at admission
3. Very severe anaemia

Recruitment start date

10/10/2012

Recruitment end date

21/02/2013

Locations

Countries of recruitment

Uganda

Trial participating centre

Mwanamugimu Nutrition Unit
Department of Paediatrics and Child Health
Kampala
-
Uganda

Sponsor information

Organisation

University of Copenhagen (Denmark)

Sponsor details

Nørregade 10
Copenhagen
1165
Denmark
+45 (0)35 32 26 26
ku@ku.dk

Sponsor type

University/education

Website

http://www.ku.dk/english/

Funders

Funder type

University/education

Funder name

Københavns Universitet

Alternative name(s)

University of Copenhagen, KU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Denmark

Funder name

Augustinus Fonden

Alternative name(s)

Augustinus Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Denmark

Funder name

Lundbeckfonden

Alternative name(s)

Lundbeck Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Denmark

Funder name

Brødrene Hartmanns Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Arvid Nielsens Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Axel Muusfeldts Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Aase and Einar Danielsens Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Torkild Steenbecks Scholarship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Changes in plasma phosphate during in-patient treatment of children with severe acute malnutrition: an observational study . Namusoke H, Hother AL, Rytter MJH, Kæstel P, Babirekere-Iriso E, Fabiansen C, Girma T, Ritz C, Michaelsen KF, Briend A, Friis H. Tentative publication date: November 1, 2015
2. Essential fatty acid composition and correlates in children with severe acute malnutrition. Babirekere-Iriso E, Lauritzen L, Mortensen CG, Rytter MJH, Mupere E, Namusoke H, Michaelsen KF, Briend A, Stark KD, Metherel AH, Friis H. Tentative publication date: January 1, 2016
3. Gut microbiota in children hospitalized with oedematous and non-oedematous severe acute malnutrition in Uganda. Kristensen KHS; Wiese M; Rytter MJH; Özcam M; Hansen LH; Namusoke H; Friis H; Nielsen DS . Tentative publication date: February 1, 2016
Correlates of thymus size and changes during treatment of children with severe acute malnutrition: a cohort study. Tentative publication date: March 1, 2016
4. Risk factors for death in children during in-hospital treatment for severe acute malnutrition. Tentative publication date: April 1, 2016
5. Gut pathogens and their clinical correlates in children with severe acute malnutrition. Tentative publication date: April 1, 2016
6. Physical activity status at discharge among children admitted with severe acute malnutrition. Tentative publication date: April 1, 2016
7. Lymphocyte subsets in children with oedematous and non-oedematous severe acute malnutrition. Tentative publication date: October 1, 2016
8. Cytokine patterns and skin symptoms in children with severe acute malnutrition. Tentative publication date: October 1, 2016
9. Heart function in children with severe acute malnutrition. Tentative publication date: October 1, 2016

Intention to publish date

01/11/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26739034

Publication citations

Additional files

Editorial Notes

07/01/2016: Publication reference added.