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Severe Acute MalnutritionPhase 2ViDiSAMNCT04270643

Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition

A Phase 2 study testing Vitamin D3 in people with Severe Acute Malnutrition, run by Queen Mary University of London at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This double-blind randomized placebo-controlled controlled trial will test the hypothesis that administration of high-dose oral vitamin D supplementation to children in Lahore, Pakistan, who are recovering from complicated severe acute malnutrition will safely accelerate weight gain (primary outcome) and enhance… Read more about this study

Who is it for?
Ages 6 months to 5 years
Conditions the study is for
Severe Acute Malnutrition
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
259 participants
Where
2 sitesPakistan
Study dates
2 Dec 2021to 30 Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Consent of parent / guardian
  • Age 6-59 months at enrolment
  • Diagnosis of complicated SAM at the point of hospital admission as defined by the World Health Organisation.
  • Medical team managing the child has made the decision to discharge the child from inpatient care

Who cannot join

  • Ingestion of a dose of vitamin D>200,000 IU (5 mg) in the last 3 months
  • Known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin D hypersensitivity)
  • Known neurodevelopmental disorder (e.g. cerebral palsy)
  • HIV infection
  • Taking anti-tuberculosis treatment
  • Inability to assess child's developmental status at baseline using the Malawi Development Assessment Tool
  • Signs of rickets
  • Corrected serum calcium concentration >2.65 mmol/L on blood sample taken during the current hospital admission

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

  • Sir Ganga Ram Hospital

    Lahore

  • THQ Hospital

    Lahore

Other trials in Pakistan

About this study

This double-blind randomized placebo-controlled controlled trial will test the hypothesis that administration of high-dose oral vitamin D supplementation to children in Lahore, Pakistan, who are recovering from complicated severe acute malnutrition will safely accelerate weight gain (primary outcome) and enhance neurodevelopment, muscle mass accumulation, resolution of systemic inflammation and antimicrobial immune function (secondary outcomes).

Being tested
Vitamin D3, Placebo
Medical subject headings
Severe Acute Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Dietary supplement

    ATC code A11CC05 (cholecalciferol)

  • PlaceboDietary supplement

    Ethyl oleate

Study groups in NCT04270643
Study groupRoleWhat they receive
Vitamin DExperimentalTwo oral doses of 5 mg (200,000 international units) vitamin D3 in 1 ml ethyl oleate, given at baseline and two weeks thereafter
Receives: Dietary Supplement: Vitamin D3
PlaceboPlacebo comparatorTwo oral doses of 1 ml ethyl oleate
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean weight-for-height/length z-score

    Measured: 2 months

Secondary outcomes (23)

  1. Mean weight-for-height/length z-score

    Measured: 6 months

  2. Mean weight-for-age z-score

    Measured: 2 and 6 months

  3. Mean height/length-for-age z-score

    Measured: 2 and 6 months

  4. Mean head circumference-for-age z-score

    Measured: 2 and 6 months

  5. Mean mid-upper arm circumference

    Measured: 2 and 6 months

  6. Mean change in overall and domain-specific (gross motor, fine motor, language and social) neurodevelopmental scores, Malawi Developmental Assessment Tool

    Measured: 2 and 6 months

  7. Mean fat mass index

    Measured: 2 and 6 months

  8. Mean fat-free mass index

    Measured: 2 and 6 months

  9. Proportion of participants experiencing relapse of severe acute malnutrition

    Measured: 6 months

  10. Proportion of participants readmitted to hospital due to any cause

    Measured: 6 months

  11. Antimicrobial immune function (concentrations of inflammatory mediators in supernatants of whole blood stimulated with lipo-polysaccharide, zymosan and heat-killed Salmonella typhi)

    Measured: 2 and 6 months

  12. Serum concentrations of albumin, C-reactive protein, 25-hydroxyvitamin D, total alkaline phosphatase, parathyroid hormone, ferritin and hepcidin

    Measured: 2 and 6 months

  13. Mean haemoglobin concentration, full blood count

    Measured: 2 and 6 months

  14. Mean corpuscular volume, full blood count

    Measured: 2 and 6 months

  15. Mean corpuscular haemoglobin concentration, full blood count

    Measured: 2 and 6 months

  16. Mean neutrophil count, full blood count

    Measured: 2 and 6 months

  17. Mean lymphocyte count, full blood count

    Measured: 2 and 6 months

  18. Mean monocyte count, full blood count

    Measured: 2 and 6 months

  19. Faecal concentrations of inflammatory markers (myeloperoxidase, neopterin and alpha-1 antitrypsin)

    Measured: 2 and 6 months

  20. Faecal microbiome composition

    Measured: 2 and 6 months

  21. Proportion of participants dying

    Measured: 6 months

  22. Incidence of serious adverse events

    Measured: 6 months

  23. Incidence of adverse reactions

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start2 Dec 2021
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04270643
Sponsor's protocol ID
ViDiSAM
Acronym
ViDiSAM
Status last verified
Jul 2024
First submitted
7 Feb 2020
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval

Publications

  • Saleem J, Zakar R, Butt MS, Kaleem R, Chaudhary A, Chandna J, Jolliffe DA, Piper J, Abbas Z, Tang JCY, Fraser WD, Freemantle N, Prendergast AJ, Martineau AR. High-dose vitamin D3 to improve outcomes in the convalescent phase of complicated severe acute malnutrition in Pakistan: a double-blind randomised controlled trial (ViDiSAM). Nat Commun. 2025 Mar 15;16(1):2554. doi: 10.1038/s41467-025-57803-9.

    PubMed 40089464

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin D3 in people with Severe Acute Malnutrition, run by Queen Mary University of London at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean weight-for-height/length z-score (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04270643, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

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