Re-feeding of children with severe acute malnutrition
| ISRCTN | ISRCTN55092738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55092738 |
| Protocol serial number | N/A |
| Sponsor | University of Copenhagen (Denmark) |
| Funders | Københavns Universitet, Augustinus Fonden, Lundbeckfonden, Brødrene Hartmanns Foundation, Arvid Nielsens Foundation, Axel Muusfeldts Foundation, Aase and Einar Danielsens Foundation, Torkild Steenbecks Scholarship |
- Submission date
- 24/08/2015
- Registration date
- 02/09/2015
- Last edited
- 20/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Rolighedsvej 30
Frederiksberg
1957
Denmark
 ORCID ID |
0000-0002-2848-2940 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational cohort study with nested cross-sectional study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Re-feeding of children hospitalized with severe acute malnutrition: an observational study from Mwanamugimu Nutrition Unit, Uganda |
| Study acronym | FeedSAM |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1.Blood essential fatty acids at admission, transition, discharge, 8 weeks, 16 weeks |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/10/2012 |
| Date of final enrolment | 21/02/2013 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Kampala
-
Uganda
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 14/03/2017 | 20/12/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/12/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2016 reference.
30/12/2016: Publication reference added.
07/01/2016: Publication reference added.
