Meta-analysisindependent cross-checkabstract only checked★ key study I-SUP-02 in-depth review
Folic acid and birth defects (Cochrane)
Effects and safety of periconceptional oral folate supplementation for preventing birth defects.
Overview
De-Regil LM et al.. Cochrane Database Syst Rev 2015 · PMID 26662928 · DOI 10.1002/14651858.CD007950.pub3
Folic acid lowered neural tube defects by about 69%.
Does the study support the specific claim? No · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Folate and birth defects.
- How was the study done?
Cochrane.
- How many people, animals or samples were studied?
7,391.
- What was actually found?
Fewer NTDs.
- How large was the observed effect?
RR 0.31.
- What do the results mean in everyday life?
Take folic acid when planning pregnancy.
- What does it say about Elawady's specific claim?
Contradicts C-SUP-10.
- Do the results apply to Germany and Europe?
Applicable.
- What can explicitly not be concluded from this study?
Other anomalies.
Scientific in-depth review
1. Full reference
- Authors
- De-Regil LM et al.
- Journal
- Cochrane Database Syst Rev
- Year
- 2015
- Identifier
- PMID 26662928 DOI 10.1002/14651858.CD007950.pub3
- Verification
- verified – PubMed efetch 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Luz Maria De‐Regil: I am a full time staff of the Micronutrient Initiative, an International NGO that supports research projects and large scale programmes to improve vitamin and mineral consumption among the most vulnerable populations. Juan Pablo Peña‐Rosas and Pura Rayco‐Solon: The World Health Organization gratefully acknowledges the financial contribution of the Bill & Melinda Gates Foundation, Micronutrient Initiative, the Centers for Disease Control and Prevention (CDC), the US Agency for International development (USAID), the Global Alliance for Improved Nutrition (GAIN) and Harvest Plus towards the work in the area of nutrition. Donors do not fund specific guidelines and do not participate in any decision related to the guideline development process, including the composition of research questions, membership of the guideline groups, conduct and interpretation of systematic reviews, or formulation of recommendations. Ana C Fernández‐Gaxiola: none known.
2. Research question
Effects and safety of periconceptional folate supplementation
3. Study design and population
- Study design
- Meta-analysis – Cochrane systematic review of RCTs/quasi-RCTs
- Population
Women of reproductive age
- Country
Multinational
- Period
to Aug 2015
- Sample size
5 trials, 7,391 women
- Inclusion and exclusion criteria
RCTs
4. Methods and endpoints
- Exposure / intervention
Daily folic acid (alone or with micronutrients)
- Comparator
No intervention/placebo/micronutrients without folate
- Endpoints
NTDs, other anomalies, outcomes
- Statistical methods
GRADE
5. Actual results
- Results
NTDs RR 0.31 (0.17–0.58), 6,708 births, high-quality evidence; recurrence RR 0.34 (0.18–0.64); effect not modified by dose ≥400 µg.
- Absolute risks
not reported in abstract excerpt
- Authors' conclusion
Folic acid has a protective effect against NTDs.
6. Strengths
- Cochrane
- High-quality evidence
7. Weaknesses
- Only one trial low risk of bias
- Author COI (NGO)
8. Risk of bias
- Orienting tool
- AMSTAR 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
9. Assessment of the statistical interpretation
10. Relevance to the specific claim
11. Independent contrary findings
12. Transferability to Germany and Europe
High.
13. Overall methodological judgement
High-certainty benefit.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
15. Linked fact checks
- No one needs vitamins or supplements: 'there is no such thing as dietary supplements', the body makes its own vitamins, and vitamins are on the forbidden list. – Studies contradicting or limiting the claim