Case-control studyindependent cross-checkabstract checked★ key study I-VEG-113 in-depth review

Stored vegetable purees caused infant methaemoglobinaemia

Methemoglobinemia induced by vegetable intake in infants in northern Spain.

Overview

Martinez A et al.. J Pediatr Gastroenterol Nutr 2013 · PMID 23287806 · DOI 10.1097/MPG.0b013e3182849d2b

In 78 Spanish infants, purees made more than a day in advance and nitrate-rich leaves such as borage and chard were linked to methaemoglobinaemia.

Does the study support the specific claim? Yes · Methodological quality: low

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Identify risk factors for vegetable-related methaemoglobinaemia.

How was the study done?

Case series with case-control comparison.

How many people, animals or samples were studied?

78 cases, 78 controls.

What was actually found?

Storage >24 h and borage/chard strongly associated.

How large was the observed effect?

OR 17.4 to 24.9 for stored purees.

What do the results mean in everyday life?

Prepare infant vegetable purees fresh or freeze them; avoid very high-nitrate leaves for young infants.

What are the study's limitations?

Small, bivariate.

What does it say about Elawady's specific claim?

Supports the infant-specific claim.

Do the results apply to Germany and Europe?

European; applicable.

What can explicitly not be concluded from this study?

Cannot show risk for adults or for fresh, properly stored purees.

Scientific in-depth review

1. Full reference

Authors
Martinez A et al.
Journal
J Pediatr Gastroenterol Nutr
Year
2013
Identifier
PMID 23287806 DOI 10.1097/MPG.0b013e3182849d2b
Verification
verified – PubMed efetch 2026-10-26; Crossref 2026-10-26
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

Which vegetables and practices are associated with diet-induced methaemoglobinaemia in infants?

3. Study design and population

Study design
Case-control study – Case series (78 cases, 1987-2010) with matched case-control analysis and nitrate measurement of vegetables
Population

Infants with diet-induced methaemoglobinaemia, Pamplona; 78 age- and sex-matched controls

Country

Spain

Period

1987-2010

Sample size

78 cases, 78 controls

Inclusion and exclusion criteria

not stated in abstract

4. Methods and endpoints

Exposure / intervention

Vegetable types in purees, time from preparation to use, breast-feeding

Comparator

Matched controls

Endpoints

Methaemoglobinaemia

Statistical methods

Bivariate logistic regression

5. Actual results

Results

Borage OR 5.2 (1.1-24.6); chard OR 2.0 (0.4-8.7); puree prepared 24-48 h before OR 17.4 (3.5-86.3), >48 h OR 24.9 (3.3-187.6); breast-feeding OR 10.4 (1.9-57.2). Mean nitrate: borage 3,968 mg/kg, chard 2,811 mg/kg.

Absolute risks

not reported

Authors' conclusion

Main factors: time from puree preparation to use (>24 h), certain vegetables (borage, chard), and breast-feeding.

6. Strengths

  • Largest series identified
  • Controls and nitrate measurements

7. Weaknesses

  • Bivariate analysis only
  • Wide CIs
  • Single region; retrospective

8. Risk of bias

Orienting tool
ROBINS-E
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
high
Rationale

Retrospective, bivariate, recall bias possible.

9. Assessment of the statistical interpretation

CIs log-symmetric but very wide (stats/C-VEG-07_infant_nitrate.py); storage time has the strongest and most precise association.

10. Relevance to the specific claim

Confirms vegetable-induced methaemoglobinaemia in infants and shows that storage of purees is a key modifiable factor.

11. Independent contrary findings

None contradicting the infant risk.

12. Transferability to Germany and Europe

European data.

13. Overall methodological judgement

Supports the claim for infants and refines it: freshness/storage and specific high-nitrate vegetables matter.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualitylow
Risk of biashigh
Precision of resultslow
Directnessdirect
Reproducibilitypartly replicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

Incidence per exposed infant.

15. Linked fact checks