The Pakistan Journal of Nutrition (PJN) supports prospective registration of clinical trials as an important measure for promoting transparency, accountability, and the responsible reporting of research involving human participants. Clinical trials submitted to PJN must comply with the registration requirements described in this policy.

Definition of a Clinical Trial

For the purposes of this policy, a clinical trial is a research study that prospectively assigns human participants, or groups of human participants, to one or more health-related interventions to evaluate their effects on health outcomes.

Health-related interventions may include, but are not limited to, dietary interventions, nutritional supplements, foods or food products, behavioral interventions, educational programs, drugs, devices, preventive strategies, or other interventions intended to modify a biomedical or health-related outcome.

Prospective Registration

Clinical trials must be registered in an acceptable publicly accessible clinical trial registry at or before the time of enrollment of the first participant. Authors should complete trial registration before participant recruitment begins whenever possible.

Registration performed only after participant enrollment has begun is considered retrospective registration and does not normally satisfy the journal's requirement for prospective registration.

Acceptable Trial Registries

Trials should be registered in a publicly accessible registry that meets recognized international standards for clinical trial registration. PJN accepts registration in a Primary Registry of the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) or in another registry accepted by the International Committee of Medical Journal Editors (ICMJE), such as ClinicalTrials.gov.

The registry record should contain sufficient information about the study design, interventions, outcomes, sponsorship, and other required trial information and should be publicly accessible.

Registration Information in the Manuscript

Manuscripts reporting the results of a clinical trial must provide the name of the trial registry and the trial registration number. This information should be clearly stated in the manuscript so that editors, reviewers, and readers can locate the corresponding registry record.

Authors are responsible for ensuring that the registration information reported in the manuscript is accurate and corresponds to the study being submitted.

Consistency Between Registration and the Manuscript

The study methods, interventions, primary and secondary outcomes, and other important elements reported in the manuscript should be consistent with the registered trial information.

If changes to the registered protocol or outcomes were made after registration, authors should update the registry where appropriate and transparently explain material changes in the manuscript. Changes must not be concealed in a manner that could result in selective or misleading reporting.

Retrospectively Registered Trials

PJN expects clinical trials to be prospectively registered. A trial that was not registered at or before the enrollment of the first participant may not satisfy the journal's normal requirements for consideration.

In exceptional circumstances, the journal may consider a retrospectively registered trial when the authors provide a clear explanation for the delayed registration and the editors determine that consideration is justified. Such consideration does not guarantee peer review or publication.

If an exception is permitted and the article is accepted, the timing of registration and the reason for delayed registration should be transparently disclosed in the published article.

Observational Studies

Observational studies in which investigators do not prospectively assign participants to a health-related intervention are not normally considered clinical trials under this policy and are therefore not generally subject to mandatory clinical trial registration.

Authors may nevertheless register observational or other prospective research when registration is appropriate to the study design or required by an institution, funder, regulator, or other applicable authority.

Secondary Analyses of Registered Clinical Trials

A secondary analysis of data from an existing registered clinical trial does not normally require registration as a new clinical trial when no new prospective intervention is being assigned. The manuscript should identify and provide the registration number of the original trial from which the data were obtained.

Ethics Approval and Trial Registration

Clinical trial registration and research ethics approval are separate requirements. Registration of a trial does not replace review and approval by an appropriate ethics committee or institutional review board, and ethical approval does not replace the requirement for prospective trial registration.

Authors must comply with the journal's Research Ethics Policy, including requirements relating to ethical approval and informed consent.

Data Sharing

Manuscripts reporting clinical trials should include an appropriate Data Availability Statement in accordance with the journal's Data Sharing Policy. Where applicable, authors should also provide information concerning the availability of de-identified participant data and related study materials.

Registration Does Not Constitute Prior Publication

Public registration of a clinical trial in an accepted trial registry does not, by itself, constitute prior publication and does not prevent consideration of the resulting manuscript by PJN.

Failure to Comply

The journal may verify trial registration information during editorial assessment or peer review. Authors may be asked to provide clarification when registration is missing, incomplete, retrospective, or inconsistent with the submitted manuscript.

Failure to meet the journal's clinical trial registration requirements may result in the manuscript not being considered for publication. Misrepresentation or deliberate concealment of trial registration information may also be addressed under the journal's Publication Ethics and Research Misconduct policies.

Author Responsibility

Authors are responsible for registering eligible clinical trials in a timely manner, maintaining accurate and current registry information, reporting the registration number correctly, and complying with any additional registration requirements imposed by applicable laws, regulations, institutions, ethics committees, or funding organizations.